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    Clinical Trial Results:
    Determination of antifungal activity of Loceryl® Nail Lacquer 5% when used concomitantly with a cosmetic nail varnish compared to a Loceryl® Nail Lacquer 5% alone in treatment of toenail Distal Subungual Onychomycosis

    Summary
    EudraCT number
    		 2013-000544-26
    Trial protocol
    		 IS  
    Global end of trial date
    21 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2020
    First version publication date
    24 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.29106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02321098
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D
    Sponsor organisation address
    2400 Route des colles - Les templiers, Biot, France, 06410
    Public contact
    Clinical Project manager, Galderma R&D, 33 493957051, farzaneh.sidou@galderma.com
    Scientific contact
    Clinical Project manager, Galderma R&D, 33 493957051, farzaneh.sidou@galderma.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 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to compare the efficacy, in terms of antifungal activity of Loceryl Nail Lacquer (amorolfine) associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles of the International Conference of Harmonization (ICH) Good Clinical Practice (GCP), the Declaration of Helsinki (1964 and subsequent amendments) and applicable regulatory requirements.
    Background therapy
    		 All subjects used test product Loceryl Nail Lacquer (NL) during the whole study period. During the first 12 weeks of the study half of subjects applied a cosmetic varnish 24 hours after that of Loceryl NL. No other product was used during the study. At week 12 visit eligible subjects entered to the second period of the study to apply Loceryl NL additional 15 months.
    Evidence for comparator
    		 Onychomycosis can have a marked effect on a subject’s social life. Several studies clearly documented that Onychomycosis had a substantial negative effect on the quality of life (QoL) of subjects. Subjects’ embarrassment has generated a strong demand for allowing the concomitant use of a cosmetic Nail Lacquer to mask the diseased nail until clinical improvement with their treatment. Unfortunately, data are lacking with regard to possible interactions between cosmetic Nail Lacquers and Loceryl Nail Lacquer. The present study was to evaluate if antifungal activity of Loceryl Nail Lacquer was modified when a cosmetic varnish was applied on the affected toenails at least 24 hours after application of Loceryl Nail Lacquer.
    Actual start date of recruitment
    11 Feb 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 15 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Iceland: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    36
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at a single center in Iceland between 11 February 2014 (first subject screened) to 21 January 2016 (last subject completed follow-up period).

    Pre-assignment
    Screening details
    		 A total of 98 subjects were screened to have a mycological sampling of the Target nail (big toenail). Among them 50 subjects were randomized and 48 completed the study.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Loceryl + Cosmetic Varnish
    Arm description
    		 Subjects applied Loceryl Nail Lacquer once a week in the morning for 12 weeks and cosmetic varnish was applied once a week in the morning (24 hours after application of Loceryl Nail Lacquer).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loceryl Nail Lacquer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated nail lacquer
    Routes of administration
    Topical use
    Dosage and administration details
    Loceryl Nail Lacquer was applied once a week in the morning.

    Investigational medicinal product name
    Cosmetic Varnish
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous suspension
    Routes of administration
    Topical use
    Dosage and administration details
    Cosmetic varnish was applied once a week in the morning (24 hours after application of Loceryl Nail Lacquer).

    Arm title
    		 Loceryl Nail Lacquer Alone
    Arm description
    		 Subjects applied Loceryl Nail Lacquer alone once a week in the morning for 12 weeks after filing down the affected toenails.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loceryl Nail Lacquer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated nail lacquer
    Routes of administration
    Topical use
    Dosage and administration details
    Loceryl Nail Lacquer alone was applied once weekly in the morning for 12 weeks after filing down the affected toenails.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was an investigator blinded study.
    Number of subjects in period 1
    		Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone
    Started
    26
    24
    Completed
    25
    23
    Not completed
    1
    1
         Lost to follow-up
    1
    1
    Period 2
    Period 2 title
    Follow Up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [2]

    Arms
    Arm title
    		 Loceryl Nail Lacquer up to Additional 15 months
    Arm description
    		 Subjects without clinical signs of aggravation of onychomycosis at Week 12 in both the reporting arms of treatment period continued to apply Loceryl Nail Lacquer once a week in the morning for additional 15 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loceryl Nail Lacquer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated nail lacquer
    Routes of administration
    Topical use
    Dosage and administration details
    Loceryl Nail Lacquer was applied once a week in the morning.

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was an investigator blinded study.
    Number of subjects in period 2 [3]
    		Loceryl Nail Lacquer up to Additional 15 months
    Started
    29
    Completed
    21
    Not completed
    8
         Consent withdrawn by subject
    1
         Lost to follow-up
    1
         Lack of efficacy
    6
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: This was an additional follow up period after the treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Loceryl + Cosmetic Varnish
    Reporting group description
    		 Subjects applied Loceryl Nail Lacquer once a week in the morning for 12 weeks and cosmetic varnish was applied once a week in the morning (24 hours after application of Loceryl Nail Lacquer).

    Reporting group title
    Loceryl Nail Lacquer Alone
    Reporting group description
    		 Subjects applied Loceryl Nail Lacquer alone once a week in the morning for 12 weeks after filing down the affected toenails.

    Reporting group values
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone Total
    Number of subjects
    		 26 24 50
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.1 ( 12 ) 53.7 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 4 11
        Male
    		 19 20 39
    Race
    Units: Subjects
        White
    		 26 24 50

    End points

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    End points reporting groups
    Reporting group title
    Loceryl + Cosmetic Varnish
    Reporting group description
    		 Subjects applied Loceryl Nail Lacquer once a week in the morning for 12 weeks and cosmetic varnish was applied once a week in the morning (24 hours after application of Loceryl Nail Lacquer).

    Reporting group title
    Loceryl Nail Lacquer Alone
    Reporting group description
    		 Subjects applied Loceryl Nail Lacquer alone once a week in the morning for 12 weeks after filing down the affected toenails.
    Reporting group title
    Loceryl Nail Lacquer up to Additional 15 months
    Reporting group description
    		 Subjects without clinical signs of aggravation of onychomycosis at Week 12 in both the reporting arms of treatment period continued to apply Loceryl Nail Lacquer once a week in the morning for additional 15 months.

    Primary: Antifungal Activity of Loceryl Nail Lacquer

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    End point title
    		 Antifungal Activity of Loceryl Nail Lacquer
    End point description
    Antifungal activity was measured by the diameter of zones of inhibition in toenail clippings from the target nail and all affected treated toenails. The Intent-to-Treat (ITT) population consisted of the subjects enrolled and randomized in the study. Here, the number of subjects analyzed refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Primary
    End point timeframe
    Week 12/early termination (ET) visit
    End point values
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone
    Number of subjects analysed
    25
    23
    Units: Milimeter
        arithmetic mean (standard deviation)
    53.6 ( 9.1 )
    53.5 ( 6.2 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Loceryl + Cosmetic Varnish v Loceryl Nail Lacquer Alone
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.942 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - P-value for between treatment difference, by CMH test based on ridit scores.

    Secondary: Number of Subjects with Negative Mycological Culture Results

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    End point title
    		 Number of Subjects with Negative Mycological Culture Results
    End point description
    Number of subjects with negative (absence) mycological culture results were reported. ITT population population consisted of the subjects enrolled and randomized in the study. Here, the number of subjects analyzed refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 12/early termination (ET) visit
    End point values
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone
    Number of subjects analysed
    25
    23
    Units: Number of subjects
    25
    23
    No statistical analyses for this end point

    Secondary: Investigator-Assessed Disease Improvement

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    End point title
    		 Investigator-Assessed Disease Improvement
    End point description
    Disease improvement by Investigator was assessed on a 3-point scale where 1=Improved, 2=Stable, 3=Worse. Investigator-Assessed disease improvement was reported. ITT population consisted of the subjects enrolled and randomized in the study. Here, the number of subjects analyzed refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 12/early termination (ET) visit
    End point values
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone
    Number of subjects analysed
    25
    23
    Units: Units on scale
        log mean (standard deviation)
    2.12 ( 0.60 )
    2.09 ( 0.51 )
    No statistical analyses for this end point

    Secondary: Subject-Assessed Disease Improvement

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    End point title
    		 Subject-Assessed Disease Improvement
    End point description
    Subject-assessed disease improvement assessment was assessed on across a 3-point scale where 1=Improved, 2=Stable, 3=Worse. Subject-assessed disease improvement was reported. ITT population consisted of the subjects enrolled and randomized in the study. Here, the number of subjects analyzed refer to the subjects evaluable for this outcome at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 12/early termination (ET) visit
    End point values
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone
    Number of subjects analysed
    25
    23
    Units: Units on scale
        log mean (standard deviation)
    1.44 ( 0.65 )
    1.22 ( 0.42 )
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs)

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    End point title
    		 Number of subjects with Adverse Events (AEs)
    End point description
    An adverse event (AE) was any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal/investigational product, whether or not related to the medicinal/investigational products or to the study procedures. Thus any new sign, symptom or disease, or clinically significant increase in the intensity of an existing sign, symptom or disease was considered as an AE. Number of subjects with AEs was reported.
    End point type
    Secondary
    End point timeframe
    From start of the study to end of Follow up period (up to Month 18)
    End point values
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone Loceryl Nail Lacquer up to Additional 15 months
    Number of subjects analysed
    26
    24
    29
    Units: Subjects
    13
    11
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of the study to end of Follow up period (up to Month 18)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Loceryl + Cosmetic Varnish
    Reporting group description
    		 Subjects applied Loceryl Nail Lacquer once a week in the morning for 12 weeks and cosmetic varnish was applied once a week in the morning (24 hours after application of Loceryl Nail Lacquer).

    Reporting group title
    Loceryl Nail Lacquer Alone
    Reporting group description
    		 Subjects applied Loceryl Nail Lacquer alone once a week in the morning for 12 weeks after filing down the affected toenails.

    Reporting group title
    Loceryl Nail Lacquer up to Additional 15 months
    Reporting group description
    		 Subjects without clinical signs of aggravation of onychomycosis at Week 12 in both the reporting arms of treatment period continued to apply Loceryl Nail Lacquer once a week in the morning for additional 15 months.

    Serious adverse events
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone Loceryl Nail Lacquer up to Additional 15 months
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 29 (6.90%)
         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)
    Tonsil cancer
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
    		 Loceryl + Cosmetic Varnish Loceryl Nail Lacquer Alone Loceryl Nail Lacquer up to Additional 15 months
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    4 / 24 (16.67%)
    10 / 29 (34.48%)
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 26 (0.00%)
    4 / 24 (16.67%)
    5 / 29 (17.24%)
         occurrences all number
    0
    4
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 24 (8.33%)
    3 / 29 (10.34%)
         occurrences all number
    1
    2
    3
    Sinusitis
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Tonsillitis
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    2
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2014
    Amendment 1: Addition of a 15-month Follow-up period with photographic assessment every 3 months.

    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.
    None reported
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