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    Clinical Trial Results:
    Phase III, multicentre, randomised, double blind, parallel-group, clinical trial to evaluate the efficacy and safety of a new medicated nail lacquer for the treatment of toenail fungal infection

    Summary
    EudraCT number
    		 2016-003784-19
    Trial protocol
    		 ES   LV  
    Global end of trial date
    16 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RJ-CPX01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorio Reig Jofre, SA
    Sponsor organisation address
    C/Gran Capità, 10, San Joan Despí, Barcelona, Spain, 08970
    Public contact
    Clinical R&D, Laboratorio Reig Jofre, SA, 0034 93 480 67 10 , Jordi.Picas@reigjofre.com
    Scientific contact
    Clinical R&D, Laboratorio Reig Jofre, SA, 0034 93 480 67 10 , Jordi.Picas@reigjofre.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of RJ-0265, in terms of complete cure (defined as complete replacement of the diseased nail by new healthy nail and conversion to negative on Dermatophyte Test Strip (DTS) and on culture), in comparison with placebo, for the treatment of toenail onychomycosis due to dermatophyte fungi, at week 52.
    Protection of trial subjects
    The protocol and consent forms were submitted to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent forms (if applicable) after initial IEC/IRB approval were submitted to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki. Local regulations at each participating country were also followed.
    Background therapy
    		 None (not applicable)
    Evidence for comparator
    		 Onytec is the active comparator. Onytec is a currently marketed ciclopirox nail lacquer 80mg/g. The invetigational product, RJ-0265, is a new ciclopirox nail lacquer 80 mg/g
    Actual start date of recruitment
    03 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 201
    Country: Number of subjects enrolled
    Latvia: 101
    Country: Number of subjects enrolled
    Mexico: 79
    Worldwide total number of subjects
    381
    EEA total number of subjects
    302
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    285
    From 65 to 84 years
    96
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment starte on 03-Aug-17 (first patient first visit) and finished on 16-Dec-19 (last patient last visit). The countries contributed recruiting patients for this clinical trial: Spain, Latvia and Mexico

    Pre-assignment
    Screening details
    		 A total of 1430 subject were screened to reach 381 analysed for safety, 376 for efficacy and 255 completers

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RJ-0265
    Arm description
    		 RJ-0265 applied once daily (in the evening) as a thin layer, for a period of 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RJ-0265
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Applied once daily (in the evening) as a thin layer

    Arm title
    		 Active control (Ony-Tec)
    Arm description
    		 Ony-Tec applied once daily (in the evening) as a thin layer, for a period of 48 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ony-Tec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Applied once daily (in the evening) as a thin layer

    Arm title
    		 Placebo
    Arm description
    		 Applied once daily (in the evening) as a thin layer, for a period of 48 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Applied once daily (in the evening) as a thin layer

    Number of subjects in period 1
    		RJ-0265 Active control (Ony-Tec) Placebo
    Started
    127
    128
    126
    Completed
    83
    88
    84
    Not completed
    44
    40
    42
         Physician decision
    5
    4
    5
         Consent withdrawn by subject
    5
    2
    6
         Adverse event, non-fatal
    1
    2
    -
         Subject's decision
    30
    28
    25
         undefined
    2
    -
    5
         undifined
    -
    4
    -
         Protocol deviation
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RJ-0265
    Reporting group description
    		 RJ-0265 applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group title
    Active control (Ony-Tec)
    Reporting group description
    		 Ony-Tec applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group values
    		 RJ-0265 Active control (Ony-Tec) Placebo Total
    Number of subjects
    		 127 128 126 381
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 99 93 93 285
        From 65-84 years
    		 28 35 33 96
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.3 ( 11.1 ) 55.6 ( 12.7 ) 54.9 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 63 57 54 174
        Male
    		 64 71 72 207
    Race
    Units: Subjects
        White
    		 105 105 107 317
        American Indian or Alaska Native
    		 22 22 19 63
        Black or African American
    		 0 1 0 1
    Etnicity
    Units: Subjects
        Hispanic or Latino
    		 91 90 90 271
        Not Hispanic or Latino
    		 36 38 36 110

    End points

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    End points reporting groups
    Reporting group title
    RJ-0265
    Reporting group description
    		 RJ-0265 applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group title
    Active control (Ony-Tec)
    Reporting group description
    		 Ony-Tec applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Primary: Rate of complete cure assessed by an independent evaluator at week 52 (comparison between RJ-0265 and placebo)

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    End point title
    		 Rate of complete cure assessed by an independent evaluator at week 52 (comparison between RJ-0265 and placebo)
    End point description
    The primary endpoint (complete cure rate) was evaluated testing the superiority contrast, RJ-0265 versus placebo. The primary analysis was done in the ITT population, using techniques of missing imputation. The comparison between RJ-0265 and placebo emplyed Fisher´s exact test. Two-sided p- values were obtained and statistically significant results declared if p < 0.05.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    10.4 (9.99 to 12.46)
    11.1 (10.69 to 13.16)
    11.2 (10.79 to 13.26)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.839
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 7.1

    Secondary: Complete cure rate (%) assessed by independent evaluator (W52)

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    End point title
    		 Complete cure rate (%) assessed by independent evaluator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    10.4 (9.92 to 12.82)
    11.1 (10.65 to 13.29)
    11.2 (10.79 to 13.26)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.839
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 7.1
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.856
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 7.2
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.982
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.1
         upper limit
    		 7.9

    Secondary: Complete cure rate (%) assessed by independent investigator (W52)

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    End point title
    		 Complete cure rate (%) assessed by independent investigator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    9.6 (9.13 to 12.11)
    10.3 (9.86 to 12.55)
    10.4 (10 to 12.5)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.833
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 6.9
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.849
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 7
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.983
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 7.7

    Secondary: Complete cure rate (%) assessed by independent evaluator (W48)

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    End point title
    		 Complete cure rate (%) assessed by independent evaluator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    7.2 (6.65 to 10.64)
    9.5 (9.08 to 11.82)
    9.6 (9.31 to 11.39)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.493
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 4.8
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.505
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 4.8
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.984
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 7.5

    Secondary: Complete cure rate (%) assessed by investigator (W48)

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    End point title
    		 Complete cure rate (%) assessed by investigator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    9.6 (9.13 to 12.11)
    10.3 (9.92 to 12.16)
    12 (11.66 to 13.74)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.541
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 5.5
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.849
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 7
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.672
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 6.3

    Secondary: Responder’s rate (%) assessed by independent evaluator (W52)

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    End point title
    		 Responder’s rate (%) assessed by independent evaluator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    14.4 (14.2 to 16.07)
    11.9 (11.52 to 13.57)
    14.4 (13.91 to 16.44)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 8.8
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.558
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 11
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.558
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 11

    Secondary: Responder’s rate (%) assessed by investigator (W52)

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    End point title
    		 Responder’s rate (%) assessed by investigator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    17.6 (17.21 to 19.14)
    14.3 (13.75 to 16.66)
    12.8 (12.07 to 15.77)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 13.8
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.473
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 12.5
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.731
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 10.1

    Secondary: Responder’s rate (%) assessed by independent evaluator (W48)

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    End point title
    		 Responder’s rate (%) assessed by independent evaluator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    10.4 (9.87 to 12.99)
    11.9 (11.47 to 13.86)
    12.8 (12.44 to 14.52)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.553
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 5.7
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.705
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 6.5
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.829
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 7.4

    Secondary: Responder’s rate (%) assessed by investigator (W48)

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    End point title
    		 Responder’s rate (%) assessed by investigator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    16 (15.36 to 18.39)
    19 (18.28 to 21.76)
    14.4 (13.83 to 16.68)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.725
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 10.6
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.525
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 6.4
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.323
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 13.9

    Secondary: Improvement rate (%) assessed by independent evaluator (W52)

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    End point title
    		 Improvement rate (%) assessed by independent evaluator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: percentage of participants
        number (confidence interval 95%)
    27.2 (26.81 to 28.4)
    20.6 (20.09 to 22.33)
    21.6 (20.84 to 24.04)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.302
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 16.1
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.222
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 17
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.851
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 9.1

    Secondary: Improvement rate (%) assessed by investigator W52)

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    End point title
    		 Improvement rate (%) assessed by investigator W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    25.6 (25.16 to 27.02)
    21.4 (20.81 to 23.43)
    20 (19.24 to 22.51)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 15.9
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.436
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 14.6
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.78
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 11.4

    Secondary: Improvement rate (%) assessed by independent evaluator W48)

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    End point title
    		 Improvement rate (%) assessed by independent evaluator W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    21.6 (20.94 to 23.74)
    24.6 (23.85 to 27.13)
    19.2 (18.57 to 21.36)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.638
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 12.4
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.572
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 7.4
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 15.5

    Secondary: Improvement rate (%) assessed by investigator (W48)

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    End point title
    		 Improvement rate (%) assessed by investigator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    24 (23.15 to 26.58)
    31.7 (30.55 to 35.46)
    18.4 (17.64 to 21)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.278
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 15.6
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.171
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.6
         upper limit
    		 3.3
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 23.7

    Secondary: Decrease of disease nail area (%) to <10% of total assessed by independent evaluator (W52)

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    End point title
    		 Decrease of disease nail area (%) to <10% of total assessed by independent evaluator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    21.8 (21.37 to 23.31)
    18.4 (17.85 to 20.42)
    17.6 (16.9 to 20.06)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.407
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 14
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.506
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 13.3
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.869
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 10.4

    Secondary: Decrease of disease nail area (%) to <10% of total assessed by investigator (W52)

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    End point title
    		 Decrease of disease nail area (%) to <10% of total assessed by investigator (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    34.8 (34.32 to 36.35)
    22.2 (21.63 to 24.09)
    21.6 (20.94 to 23.77)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.549
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 13.6
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.63
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 13
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.905
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 10.8

    Secondary: Decrease of disease nail area (%) to <10% of total assessed by independent evaluator (W48)

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    End point title
    		 Decrease of disease nail area (%) to <10% of total assessed by independent evaluator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    15.3 (14.84 to 17.17)
    14.4 (13.96 to 16.17)
    16 (15.52 to 17.89)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.883
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 8.5
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.838
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 9.9
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.725
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 7.4

    Secondary: Decrease of disease nail area (%) to <10% of total assessed by investigator (W48)

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    End point title
    		 Decrease of disease nail area (%) to <10% of total assessed by investigator (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    21.6 (21.06 to 23.41)
    21.4 (20.83 to 23.31)
    20.8 (20.23 to 22.73)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.887
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 10.9
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.974
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 10.3
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.903
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 10.7

    Secondary: Conversion to negative KOH/DTS rate (W52)

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    End point title
    		 Conversion to negative KOH/DTS rate (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    40 (39.38 to 41.69)
    40.5 (39.57 to 43.13)
    30.4 (29.49 to 32.98)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.112
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 21.1
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.939
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4
         upper limit
    		 11.5
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 21.5

    Secondary: Conversion to negative KOH/DTS rate (W48)

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    End point title
    		 Conversion to negative KOH/DTS rate (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    34.4 (33.62 to 36.57)
    40.5 (39.72 to 42.67)
    34.4 (33.81 to 36.09)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.6
         upper limit
    		 11.6
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.7
         upper limit
    		 5.8
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 17.7

    Secondary: Conversion to negative to dermatophyte by culture rate (W52)

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    End point title
    		 Conversion to negative to dermatophyte by culture rate (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    47.2 (46.62 to 48.77)
    46 (45.02 to 48.72)
    34.4 (33.37 to 37.25)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 24.5
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.853
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 13.3
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    11.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 23.3

    Secondary: Conversion to negative to dermatophyte by culture rate (W48)

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    End point title
    		 Conversion to negative to dermatophyte by culture rate (W48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    59.2 (57.35 to 64.41)
    69 (68.08 to 71.59)
    32 (29.2 to 40.15)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    27.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.9
         upper limit
    		 38.3
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.3
         upper limit
    		 2
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.9
         upper limit
    		 47.6

    Secondary: Conversion to negative to dermatophyte by culture and negative to KOH/DTS rate (%) (W52)

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    End point title
    		 Conversion to negative to dermatophyte by culture and negative to KOH/DTS rate (%) (W52)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    32 (31.55 to 33.35)
    27 (26.31 to 29.18)
    23.2 (22.31 to 25.94)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.119
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 19.6
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.383
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 16.1
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.489
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 14.4

    Secondary: nConversion to negative to dermatophyte by culture and negative to KOH/DTS rate (%) (48)

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    End point title
    		 nConversion to negative to dermatophyte by culture and negative to KOH/DTS rate (%) (48)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Number of subjects analysed
    125
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    31.2 (30.31 to 33.73)
    40.5 (39.13 to 44.62)
    22.4 (21.5 to 25.18)
    Statistical analysis title
    		 RJ-0265 vs. Placebo
    Comparison groups
    RJ-0265 v Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.116
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 19.5
    Statistical analysis title
    		 RJ-0265 vs. Ony-Tec
    Comparison groups
    RJ-0265 v Active control (Ony-Tec)
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.125
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    -9.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.8
         upper limit
    		 2.6
    Statistical analysis title
    		 Ony-Tec vs. Placebo
    Comparison groups
    Active control (Ony-Tec) v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Fisher exact
    Parameter type
    		 Percentage Difference
    Point estimate
    18.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.6
         upper limit
    		 28.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From writen informed consent to the end of the study (whaterver the reason is) [maximum 1 year and 6 weeks]
    Adverse event reporting additional description
    The Safety Analysis Set included all randomized participants
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    RJ-0265
    Reporting group description
    		 RJ-0265 applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group title
    Active control (Ony-Tec)
    Reporting group description
    		 Ony-Tec applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Applied once daily (in the evening) as a thin layer, for a period of 48 weeks.

    Serious adverse events
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 127 (2.36%)
    6 / 128 (4.69%)
    2 / 126 (1.59%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cancer
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Bladder cancer
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ankle fracture
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    post surgical infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RJ-0265 Active control (Ony-Tec) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 127 (17.32%)
    24 / 128 (18.75%)
    23 / 126 (18.25%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Infected neoplasm
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Dental implantation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    2
    0
    1
    Cataract operation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Inguinal hernia repair
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    2
    Knee operation
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    2
    Tooth extraction
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Wisdom teeth removal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 128 (1.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    Pain
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    1
    Asthma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 128 (1.56%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    1
    Depression
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    1
    Dental restoration failure
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    2
    Limb injury
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 128 (0.78%)
    2 / 126 (1.59%)
         occurrences all number
    5
    2
    7
    Sciatica
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 128 (0.78%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    1
    Perineurial cyst
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Intestinal congestion
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Onychalgia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    3
    Nail discolouration
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    2
    0
    1
    Dermatitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    3
    0
    Rosacea
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 128 (1.56%)
    2 / 126 (1.59%)
         occurrences all number
    0
    3
    2
    back pain
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    Arthralgia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    neck pain
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Periarthritis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Periostitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Tendonitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 127 (3.15%)
    4 / 128 (3.13%)
    4 / 126 (3.17%)
         occurrences all number
    4
    4
    4
    Nasopharyngitis
         subjects affected / exposed
    4 / 127 (3.15%)
    2 / 128 (1.56%)
    3 / 126 (2.38%)
         occurrences all number
    4
    3
    4
    Ear infection
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 128 (2.34%)
    0 / 126 (0.00%)
         occurrences all number
    0
    3
    0
    Bronchitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Dengue
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    gastroenteritis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2017
    The amendment consisted of the following changes: - Change of one of the protocol’s diagnostic test (from KOH-based microscopic examination to Diafactory Tinea Unguium commercial test kit) to increase the sensitivity and reduce examiner subjectivity. It also provided an immediate diagnostic. - Participant’s age extended from 70 to 75 years. - Change in the number and distribution of participating centres (from 30 to 31). Taking advantage of this amendment, the study calendar was updated, and typographic errors of the previous version were corrected.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Elevated number of screening failures (90.8%) due to lack of a positive culture at screening before randomization
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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