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    Clinical Trial Results:
    A double-blind, randomised, placebo-controlled clinical study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 1 and 2%, applied once daily for 12 weeks in patients with mild to moderate facial acne vulgaris

    Summary
    EudraCT number
    		 2016-000540-33
    Trial protocol
    		 HU   CZ   SK  
    Global end of trial date
    26 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2022
    First version publication date
    10 Jun 2022
    Other versions
    Summary report(s)
    		 Clinical Summary Results

    Trial information

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    Trial identification
    Sponsor protocol code
    GED-0507-ACN-01-16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PPM SERVICES SA
    Sponsor organisation address
    Viale Serfontana 10, Morbio Inferiore,, Switzerland, 6834
    Public contact
    Angelo Vaccani, CROSS Reserach, +41 916300510, angelo.vaccani@croalliance.com
    Scientific contact
    Angelo Vaccani, CROSS Reserach, +41 916300510, angelo.vaccani@croalliance.com
    Sponsor organisation name
    PPM Services S.A.
    Sponsor organisation address
    Viale Serfontana 10, Morbio Inferiore, Switzerland, CH-6834
    Public contact
    Dr Salvatore Bellinvia (Sponsor medical officer), PPM Services S.A., 0041 916969710, sbellinvia@ppmservices.ch
    Scientific contact
    Dr Salvatore Bellinvia (Sponsor medical officer), PPM Services S.A., +41 91 69 61 712, sbellinvia@ppmservices.ch
    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
    26 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to evaluate the efficacy and the local and systemic safety of 1% and 2% N-Acetyl-GED-0507-34-Levo gel, in comparison to the matching placebo gel, applied once daily for 12 weeks in patients with mild to moderate facial acne vulgaris
    Protection of trial subjects
    Data verification was required and it was performed by direct comparison with source documents, always giving due consideration to data protection and medical confidentiality. In this respect the Investigator have assured support to the monitors at all times.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2016
    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
    Slovakia: 49
    Country: Number of subjects enrolled
    Czech Republic: 49
    Country: Number of subjects enrolled
    Hungary: 49
    Worldwide total number of subjects
    147
    EEA total number of subjects
    147
    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)
    18
    Adults (18-64 years)
    129
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment took place in the following countries: Hungary, Czech Republic and Slovakia. Date of first enrolment is 4th July 2016 (first randomized patient) Date of last completed 26th January 2017 (last visit of the last patient)

    Pre-assignment
    Screening details
    		 N. 155 patients have been screened for the study and 147 patients receiving double-blind medication with a total of 6 screening failure patients

    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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IMP 1%
    Arm description
    		 N-ACETYL-GED-0507-34-LEVO GEL 1%
    Arm type
    		 Experimental

    Investigational medicinal product name
    N-ACETYL-GED-0507-34-LEVO GEL 1%
    Investigational medicinal product code
    N-ACETYL-GED-0507-34-LEVO GEL
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    1% daily dosage for 12 weeks

    Arm title
    		 IMP 2%
    Arm description
    		 N-ACETYL-GED-0507-34-LEVO GEL 2%
    Arm type
    		 Experimental

    Investigational medicinal product name
    N-ACETYL-GED-0507-34-LEVO GEL 2%
    Investigational medicinal product code
    N-ACETYL-GED-0507-34-LEVO GEL
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    2% daily dosage for 12 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    PLACEBO daily for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    placebo daily use for 12 weeks

    Number of subjects in period 1
    		IMP 1% IMP 2% Placebo
    Started
    50
    50
    47
    Completed
    46
    50
    42
    Not completed
    4
    0
    5
         Adverse event, non-fatal
    -
    -
    1
         Progressive Disease
    -
    -
    1
         Withdrawal by Parent/Guardian
    2
    -
    -
         Withdrawal by Subject
    1
    -
    2
         Lost to follow-up
    -
    -
    1
         Lack of efficacy
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 147 147
    Age categorical
    Age ranged from 14.0 to 30.0 years.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 18 18
        Adults (18-64 years)
    		 129 129
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    age ranged from 14.0 to 30.0 years.
    Units: years
        arithmetic mean (standard deviation)
    		 21.2 ( 3.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 85 85
        Male
    		 62 62

    End points

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    End points reporting groups
    Reporting group title
    IMP 1%
    Reporting group description
    		 N-ACETYL-GED-0507-34-LEVO GEL 1%

    Reporting group title
    IMP 2%
    Reporting group description
    		 N-ACETYL-GED-0507-34-LEVO GEL 2%

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Efficacy inflammatory lesions

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    End point title
    		 Efficacy inflammatory lesions
    End point description
    In the whole study period (follow-up included), for all the three analysis sets the inflammatory lesion number showed a decrease over time in the mean value. By considering Intention To Treat Set, after 12 weeks of treatment the percent changes from baseline were -45.2 for N-Acetyl-GED-0507-34-Levo 1% group, -57.2 for 2% and -28.7 for placebo. Results from pairwise two-sided multiple comparison analysis were statistically significant for N-Acetyl-GED-0507-34-Levo 2% vs placebo (p=0.0003) and N-Acetyl-GED-0507-34-Levo 1% vs placebo (p= 0.0329) but not for N-Acetyl-GED-0507-34-Levo 2% vs N-Acetyl-GED-0507-34-Levo 1% (p=0.1085). Similar patterns were observed both in the mITT set and in Sub-Group Analysis N1 Set.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 IMP 1% IMP 2% Placebo
    Number of subjects analysed
    50
    50
    47
    Units: -100-0
        number (not applicable)
    -45.2
    -57.2
    -28.7
    Statistical analysis title
    		 Statistical
    Statistical analysis description
    The statistical analysis was performed using SAS® version 9.3 – SAS Institute Inc, Cary, NC, USA and carried out according to ICH guidelines ICH E9: “Statistical Principles for Clinical Trials” (CPMP/ICH/363/96 September 1998). All statistical tests were carried out at a significant level (alpha level) of 0.05, two tailed.
    Comparison groups
    IMP 1% v IMP 2% v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - In addition to the descriptive analysis, an Ancova model, with baseline value as covariate and treatment as fixed factor was applied to test the null hypothesis H0: “The mean score on the changes from baseline are identical among treatment groups” (both for INF, non-INF, and TOT Les counts). Additional analysis with the ranked change (absolute or percent) in lesion count was performed with an ANCOVA model, by using ranked baseline count as covariate and treatment as factor.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    TEAEs
    Reporting group description
    		 -

    Serious adverse events
    		 TEAEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 147 (1.36%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Laboratory test abnormal
         subjects affected / exposed
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TEAEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 147 (48.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    21 / 147 (14.29%)
         occurrences all number
    21
    General disorders and administration site conditions
    APPLICATION SITE DRYNESS
         subjects affected / exposed
    19 / 147 (12.93%)
         occurrences all number
    19
    Application site exfoliation
         subjects affected / exposed
    11 / 147 (7.48%)
         occurrences all number
    11
    Application site erythema
         subjects affected / exposed
    11 / 147 (7.48%)
         occurrences all number
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 147 (2.04%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 147 (2.72%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    7 / 147 (4.76%)
         occurrences all number
    7
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    7 / 147 (4.76%)
         occurrences all number
    7
    Influenza
         subjects affected / exposed
    3 / 147 (2.04%)
         occurrences all number
    3

    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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