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    Clinical Trial Results:
    Multicentre, open label study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosis

    Summary
    EudraCT number
    		 2013-005595-17
    Trial protocol
    		 IT   DE   BE   LV   ES  
    Global end of trial date
    02 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2018
    First version publication date
    07 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM Ped-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02547701
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Polichem S.A.
    Sponsor organisation address
    Via Senago 42 D, Lugano, Switzerland, 6912
    Public contact
    Director, Clinical Development, Polichem S.A., +41 0919864024, maurizio.caserini@polichem.com
    Scientific contact
    Director, Clinical Development, Polichem S.A., +41 0919864024, maurizio.caserini@polichem.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001259-PIP02-13
    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
    02 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study was to evaluate the tolerability and safety of topical treatment with P-3058 10% once a week in pediatric subjects with onychomycosis.
    Protection of trial subjects
    The clinical trial was conducted in compliance with globally accepted standards of good clinical practice (as defined in the ICH E6 guideline for good clinical practice, January 1997), in agreement with the Declaration of Helsinki (Seoul, October 2008).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Aug 2014
    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: 3
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Latvia: 3
    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)
    16
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in Italy, Belgium, Germany, Latvia and Spain between 26 August 2014 (first subject first visit) and 02 August 2017 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 46 subjects were screened, 20 entered the study and received treatment while 26 subjects were screening failures.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Age group 2-11 years
    Arm description
    		 Pediatrics subjects with mild to moderate distal subungual onychomycosis (DSO) or White Superficial Onychomycosis (WSO) were planned for enrolment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    P-3058
    Investigational medicinal product code
    P-3058
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Nails affected by mild to moderate DSO or WSO were applied with P-3058 10% nail solution preferably at bedtime, over the nail plate, hyponychium and in the surrounding skin once a day for the first 4 weeks and then once a week according to the different dosage schedule per age group.

    Arm title
    		 Age group 12-17 years
    Arm description
    		 Pediatrics subjects with mild to moderate DSO or WSO were planned for enrollment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    P 3058
    Investigational medicinal product code
    P 3058
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Nails affected by mild to moderate DSO or WSO were applied with P-3058 10% nail solution preferably at bedtime, over the nail plate, hyponychium and in the surrounding skin once a day application for the first 4 weeks and then once a week according to the different dosage schedule per age group.

    Number of subjects in period 1
    		Age group 2-11 years Age group 12-17 years
    Started
    16
    4
    Completed
    15
    4
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Age group 2-11 years
    Reporting group description
    		 Pediatrics subjects with mild to moderate distal subungual onychomycosis (DSO) or White Superficial Onychomycosis (WSO) were planned for enrolment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.

    Reporting group title
    Age group 12-17 years
    Reporting group description
    		 Pediatrics subjects with mild to moderate DSO or WSO were planned for enrollment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.

    Reporting group values
    		 Age group 2-11 years Age group 12-17 years Total
    Number of subjects
    		 16 4 20
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.19 ( 3.12 ) 14.00 ( 1.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 1 9
        Male
    		 8 3 11
    Race
    Units: Subjects
        Black or African American
    		 1 0 1
        White
    		 14 4 18
        Other
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Age group 2-11 years
    Reporting group description
    		 Pediatrics subjects with mild to moderate distal subungual onychomycosis (DSO) or White Superficial Onychomycosis (WSO) were planned for enrolment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.

    Reporting group title
    Age group 12-17 years
    Reporting group description
    		 Pediatrics subjects with mild to moderate DSO or WSO were planned for enrollment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.

    Subject analysis set title
    Safety population (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SAF included all enrolled subjects with signed informed consent who have at least one documented application of the investigational drug and one post-baseline safety assessment.

    Primary: Local tolerability at the application site

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    End point title
    		 Local tolerability at the application site [1]
    End point description
    Local tolerability at the application site (all treated nails) was assessed during the study by means of the Severity Score for Skin Irritation. Incidence rate was calculated. Incidence Rate was calculated dividing the number of skin irritation events by the 10 toenails*time * 1000.
    End point type
    Primary
    End point timeframe
    From start of study drug administration until 12 weeks after the last dose of study treatment
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Age group 2-11 years Age group 12-17 years
    Number of subjects analysed
    16 [2]
    4 [3]
    Units: Events per 1,000 toenails-time
        number (not applicable)
    0.015
    0.000
    Notes
    [2] - SAF
    [3] - SAF
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study subject (regardless of the administration of the study treatment and its causal relationship to it). A treatment emergent AE was defined as an AE with an onset date after treatment initiation.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration until 12 weeks after the last dose of study treatment
    End point values
    		 Age group 2-11 years Age group 12-17 years
    Number of subjects analysed
    16 [4]
    4 [5]
    Units: Subject
    12
    3
    Notes
    [4] - SAF
    [5] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration until 12 weeks after the last dose of study treatment
    Adverse event reporting additional description
    Adverse event data provided below was for treatment emergent AEs. A treatment emergent AE was defined as an AE with an onset date after treatment initiation.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Age group 12-17 years
    Reporting group description
    		 Pediatrics subjects with mild to moderate DSO or WSO were planned for enrolment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.

    Reporting group title
    Age group 2-11 years
    Reporting group description
    		 Pediatrics subjects with mild to moderate DSO or WSO were planned for enrolment. However, only subjects with mild to moderate toenails DSO were included in the study. They applied P-3058 10% to all toenails according to the appropriate treatment schedule.

    Serious adverse events
    		 Age group 12-17 years Age group 2-11 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Age group 12-17 years Age group 2-11 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    12 / 16 (75.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Adnexa uteri pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Onychoclasis
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Skin irritation
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    Rash pruritic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 4 (50.00%)
    3 / 16 (18.75%)
         occurrences all number
    2
    5
    Viral infection
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Tonsillitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0

    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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