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    Clinical Trial Results:
    Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Ciclopoli® Nail Lacquer.

    Summary
    EudraCT number
    		 2015-001237-24
    Trial protocol
    		 DE  
    Global end of trial date
    16 Jun 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.105082
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02679911
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GALDERMA R&D
    Sponsor organisation address
    Les Templiers, 2400, Route des Colles, Biot, France, 06410
    Public contact
    Farzaneh Sidou, Galderma R&D, 0033 493957051, Farzaneh.sidou@galderma.com
    Scientific contact
    Farzaneh Sidou, Galderma R&D, 0033 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
    16 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare subject-reported adherence and satisfaction for two modes of treatment of Distal and Lateral Subungual Onychomycosis (DLSO) in toenail treatment with Loceryl nail lacquer (Amorolfine) and Ciclopoli nail lacquer (Ciclopirox).
    Protection of trial subjects
    This study protocol was reviewed and approved by the appropriate independent ethics committee/institutional review board prior to study initiation. This study was conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and the International Conference on Harmonization Good Clinical Practice, and in compliance with applicable regulatory requirements. All subjects who participated in this trial were fully informed about the study in accordance with the applicable regulations and guidelines and in accordance with local legal requirements. All subjects signed the informed consent form which was written in the local language and a copy of the same was given to the subject. In any medical emergency, the investigator unblinded the treatment only for the subject involved.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2015
    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
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    18
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at a single center in Germany between 18 September 2015 (first subject screened) to 16 June 2016 (last subject completed). A total of subjects completed the study.

    Pre-assignment
    Screening details
    		 A total of 20 subjects with a clinical diagnosis of DLSO on at least one toenail of each foot confirmed by positive direct microscopic examination for dermatophytes and/or yeast (including Candida) and positive culture results without matrix involvement were randomised and treated in the study. A total of 20 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    The study was considered to be an investigator-blinded study design.

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 Each subject received 2 topical treatments with Loceryl in one foot and Ciclopoli in the other foot. Loceryl (amorolfine hydrochloride 5 percent [%]) nail lacquer was applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopoli nail lacquer was applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails, if needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loceryl
    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 weekly, topically over the entire toenail plate of all affected toenails in the evening (at bed time) for 12 weeks.

    Investigational medicinal product name
    Ciclopoli
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated nail lacquer
    Routes of administration
    Topical use
    Dosage and administration details
    Ciclopoli nail lacquer was applied once daily, topically over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) for 12 weeks.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The study was considered to be an investigator-blinded study design.
    Number of subjects in period 1
    		All Subjects
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Each subject received 2 topical treatments with Loceryl in one foot and Ciclopoli in the other foot. Loceryl (amorolfine hydrochloride 5 percent [%]) nail lacquer was applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopoli nail lacquer was applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails, if needed.

    Reporting group values
    		 All Subjects Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.5 ± 8.7 -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 10 10
    Race
    Units: Subjects
        White
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Each subject received 2 topical treatments with Loceryl in one foot and Ciclopoli in the other foot. Loceryl (amorolfine hydrochloride 5 percent [%]) nail lacquer was applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopoli nail lacquer was applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails, if needed.

    Subject analysis set title
    Loceryl
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Loceryl nail lacquer was applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.

    Subject analysis set title
    Ciclopoli
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ciclopoli nail lacquer was applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails, if needed.

    Primary: Adherence rate as per label

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    End point title
    		 Adherence rate as per label
    End point description
    Adherence to medications is defined as the process by which subjects take their medications as prescribed. Subject’s adherence as per summary of product characteristics (SmPC) was defined as Loceryl nail lacquer application once weekly and Ciclopoli nail lacquer application once daily. At Baseline visit, subjects were provided with a subject diary to record on a daily/weekly basis the frequency of applications of study products (Loceryl nail lacquer and Ciclopoli nail lacquer) on the affected toenails of each foot. Adherence rate is defined as the percentage of subjects “in and off label. The analysis was performed on the intent-to-treat (ITT) population which included all subjects who were enrolled and randomised.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
    number (not applicable)
        Yes (as per label)
    85.0
    60.0
        No (off label)
    15.0
    40.0
    Statistical analysis title
    		 Loceryl Versus Ciclopoli
    Statistical analysis description
    For ‘number of subjects included in the analysis’ field: total number of subjects analysed were 20 instead of 40.
    Comparison groups
    Loceryl v Ciclopoli
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Primary: Non-adherence Count as Per Label

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    End point title
    		 Non-adherence Count as Per Label
    End point description
    Study treatment non-adherence was defined as the number of "off label" episodes. The analysis was performed on the ITT population which included all subjects who were enrolled and randomised. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point. Here '99999' signifies that standard deviation data for loceryl group was not calculated due to single subject availability for the analysis .
    End point type
    Primary
    End point timeframe
    Up to Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    1
    8
    Units: off label episodes count
        arithmetic mean (standard deviation)
    2.0 ± 99999
    3.0 ± 1.7
    Statistical analysis title
    		 Loceryl Versus Ciclopoli
    Comparison groups
    Loceryl v Ciclopoli
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Primary: Non-adherence Duration as Per Label

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    End point title
    		 Non-adherence Duration as Per Label
    End point description
    Non-adherence duration as per label is defined as the total duration of “off label” episodes assessed in days. The analysis was performed on the ITT population which included all subjects who were enrolled and randomised. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point. Here '99999' signifies that standard deviation data for loceryl group was not calculated due to single subject availability for the analysis .
    End point type
    Primary
    End point timeframe
    Up to Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    1
    8
    Units: days
        arithmetic mean (standard deviation)
    20.0 ± 99999
    3.5 ± 1.8
    Statistical analysis title
    		 Loceryl Versus Ciclopoli
    Comparison groups
    Ciclopoli v Loceryl
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.195
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Primary: Adherence Rate as Per Effective Exposure

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    End point title
    		 Adherence Rate as Per Effective Exposure
    End point description
    Adherence to medications is defined as the process by which subjects take their medications as prescribed. Subject's adherence as per effective nail exposure was defined as Loceryl nail lacquer application at least once every other week on all affected toenails of one foot and Ciclopoli nail lacquer application at least once every other day on all affected toenails of the opposite foot. Adherence rate as per effective exposure is defined as the percentage of subjects with "in" and "off" effective exposure. The analysis was performed on the ITT population which included all subjects who were enrolled and randomised.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
    number (not applicable)
        Yes (in effective exposure)
    95.0
    85.0
        No (off effective exposure)
    5.0
    15.0
    Statistical analysis title
    		 Loceryl Versus Ciclopoli
    Comparison groups
    Ciclopoli v Loceryl
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.157
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Primary: Non-adherence Count as Per Effective Exposure

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    End point title
    		 Non-adherence Count as Per Effective Exposure
    End point description
    Study treatment non-adherence was defined as the number of "off exposure" episodes. The analysis was performed on the ITT population which included all subjects who were enrolled and randomised. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point. Here '99999' signifies that standard deviation data for loceryl group was not calculated due to single subject availability for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    1
    3
    Units: off exposure episodes count
        arithmetic mean (standard deviation)
    2.0 ± 99999
    1.0 ± 0.0
    Statistical analysis title
    		 Loceryl Versus Ciclopoli
    Comparison groups
    Ciclopoli v Loceryl
    Number of subjects included in analysis
    4
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Primary: Non-adherence Duration as Per Effective Exposure

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    End point title
    		 Non-adherence Duration as Per Effective Exposure
    End point description
    Non-adherence duration as per effective exposure was defined as the total duration of “off exposure” episodes assessed in days. The analysis was performed on the ITT population which included all subjects who were enrolled and randomised. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point. Here '99999' signifies that standard deviation data for loceryl group was not calculated due to single subject availability for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    1
    3
    Units: days
        arithmetic mean (standard deviation)
    4.0 ± 99999
    1.3 ± 0.6
    Statistical analysis title
    		 Loceryl Versus Ciclopoli
    Comparison groups
    Loceryl v Ciclopoli
    Number of subjects included in analysis
    4
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Primary: Overall Preference for Loceryl or Ciclopoli

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    End point title
    		 Overall Preference for Loceryl or Ciclopoli [1]
    End point description
    Subject’s overall preference for study treatments was assessed according to a 3-grade preference scale (-1: left better than right, 0: no preference, 1: right better than left) based on subject judgment of criteria such as ease of use, smell and drying rate, where the right and left refers to the foot on which the subject applied Loceryl or Ciclopoli. The analysis was performed on the ITT population which included all subjects who were enrolled and randomised.
    End point type
    Primary
    End point timeframe
    At Week 4, Week 8 and Week 12/early discontinuation
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The data presented for this primary endpoint is not analysed by the reporting arms. So, the statistical comparisons could not be presented.
    End point values
    		 All Subjects
    Number of subjects analysed
    20
    Units: subjects
    number (not applicable)
        Week 4: Ciclopoli better than Loceryl
    9
        Week 4: No preference
    2
        Week 4: Loceryl better than Ciclopoli
    9
        Week 8: Ciclopoli better than Loceryl
    9
        Week 8: No preference
    2
        Week 8: Loceryl better than Ciclopoli
    9
        Week 12: Ciclopoli better than Loceryl
    9
        Week 12: No preference
    1
        Week 12: Loceryl better than Ciclopoli
    10
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Satisfied with Each Study Treatment as Assessed by Subject’s Questionnaire

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    End point title
    		 Percentage of Subjects Satisfied with Each Study Treatment as Assessed by Subject’s Questionnaire
    End point description
    Subject’s questionnaire aimed to collect information on what subject think about the prescribed Loceryl/Ciclopoli naillacquer treatments. There was no “right” or “wrong” answer. It consisted of 9- questions as followed: 1) where did you apply the products? 2) how much time did it take you to apply the study treatments on your nails? 3) how easy was it to spread the treatment on your nails using the package contents? 4) were you satisfied with the frequency of application of the treatments? 5) overall during the whole treatment period how easy to use did you find the treatments? 6) if you did not apply the study products as often as required, what were the reasons? 7) overall, how satisfied are you with the treatments? 8) would you consider continuing to use the treatment after the study end? 9) would you recommend the use of either of the study treatments to family or friends? Analysis was performed on the ITT population which included all subjects who were enrolled and randomized.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Loceryl Ciclopoli
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
        number (not applicable)
    95
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of the informed consent up to last visit (Week 12) or early termination
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Each subject received 2 topical treatments with Loceryl in one foot and Ciclopoli in the other foot. Loceryl (amorolfine hydrochloride 5 percent [%]) nail lacquer was applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopoli nail lacquer was applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails, if needed.

    Serious adverse events
    		 All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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