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    Clinical Trial Results:
    AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF N-ACETYL-GED-0507-34-LEVO GEL 5% IN PATIENTS WITH FACIAL ACNE

    Summary
    EudraCT number
    		 2017-003796-58
    Trial protocol
    		 IT  
    Global end of trial date
    27 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2021
    First version publication date
    14 Jul 2021
    Other versions
    Summary report(s)
    		 SUMMARY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    NAC-GED-0507-ACN-02-17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1203-0648
    Sponsors
    Sponsor organisation name
    PPM SERVICES SA
    Sponsor organisation address
    Viale Serfontana 10, Morbio Inferiore, Switzerland, 6834
    Public contact
    MEDICAL DEPARTMENT, PPM SERVICES SA, 0041 916969710, sbellinvia@ppmservices.ch
    Scientific contact
    MEDICAL DEPARTMENT, PPM SERVICES SA, 0041 916969710, 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
    11 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Local and systemic safety and tolerability of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to 5% gel in patients affected by facial acne vulgaris. Plasmatic concentration of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to the gel containing 5% of active principle
    Protection of trial subjects
    The original protocol version 1.0 of 02 October 2017 was submitted both to the Italian Regulatory Agency (AIFA) and competent Ethics Committee (IRCCS Istituti Fisioterapici Ospitalieri di Roma and received a favourable single opinion on 24 October 2017 and the authorization from AIFA on 13 December 2017, with favourable opinion by Istituto Superiore di Sanità (ISS) released on 24 November 2017. This phase I trial was conducted in the unit Centro Studi Early Phase (CSEP) of the IRCCS IFO - Istituti Fisioterapici Ospitalieri in Roma, accredited as per Determina AIFA 809/2015 to conduct phase I trials. Having obtained the favourable opinion from the competent IEC (IRCCS Istituti Fisioterapici Ospitalieri di Roma) and following the approval of the Competent Authorities (CAs) with favourable opinion by Istituto Superiore di Sanità (ISS), site was initiated after AIFA inspection on CSEP and following authorization to conduct phase I studies, in September 2018. This clinical trial (Protocol no. NAC-GED-0507-ACN-02-17 Eudract Number: 2017-003796-58) was conducted in compliance with specific regulatory requirements of the Italian Ministry of Health, including D.lgs 24 June 2003 no. 211, DPR 21 September 2001 no. 439, DM 26 April 2002, DM 21 December 2007, DM 13 September 2012, Determina AIFA 07 January 2013, Determina AIFA 809/2015. This trial was conducted in compliance with the most recent version of the Declaration of Helsinki (Fortaleza, Brazil, October 2013), the most recent version of the Good Clinical Practice (GCP), and all applicable regulatory requirements (European Directive 2001/20/EC, 04 April 2001), and Italian Laws (D.lgs no. 211, 24 June 2003 and all applicable regulations).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2018
    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
    Italy: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    10
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study initiation date: 09 October 2018 (first patient enrolled) Study completion date: 27 June 2019 (last visit of the last patient)

    Pre-assignment
    Screening details
    		 A total of 25 patients have been recruited in the study: • 10 Patients with facial acne vulgaris with IGA score = 2 (mild) • 10 Patients with facial acne vulgaris with IGA score = 3 (moderate) • 5 Patients with facial acne vulgaris with IGA score = 4 (severe)

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label

    Arms
    Arm title
    		 SIngle arm (open label study)
    Arm description
    		 N-ACETYL-GED-0507-34-LEVO GEL 5%
    Arm type
    		 Experimental

    Investigational medicinal product name
    N-ACETYL-GED-0507-34-LEVO GEL 5%
    Investigational medicinal product code
    N-ACETYL-GED-0507-34-LEVO GEL 5%
    Other name
    N-ACETYL-GED-0507-34-LEVO GEL 5%
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    N-ACETYL-GED-0507-34-LEVO GEL 5% daily application for 12 weeks

    Number of subjects in period 1
    		SIngle arm (open label study)
    Started
    25
    Completed
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All subjects randomized

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 25 25
    Age categorical
    The age ranged from 12.0 to 29.0 years (19.2 ± 4.27) with 15 adults (60.0%) and 10 minors (40.0%).
    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)
    		 10 10
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Minor
    		 0 0
        Adults
    		 0 0
    Age continuous
    The age ranged from 12.0 to 29.0 years (19.2 ± 4.27) with 15 adults (60.0%) and 10 minors (40.0%).
    Units: years
        median (standard deviation)
    		 18 ( 4.27 ) -
    Gender categorical
    As per protocol, females were enrolled only if adults (≥ 18 years old).
    Units: Subjects
        Female
    		 12 12
        Male
    		 13 13
    IGA scores
    Investigator Global Assessment
    Units: Subjects
        Mild
    		 10 10
        Moderate
    		 10 10
        Severe
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population: subjects who took at least one dose of investigational product and had at least one post-dose safety assessment.

    Subject analysis sets values
    		 Safety population
    Number of subjects
    25
    Age categorical
    The age ranged from 12.0 to 29.0 years (19.2 ± 4.27) with 15 adults (60.0%) and 10 minors (40.0%).
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    10
        Adults (18-64 years)
    15
        From 65-84 years
    0
        85 years and over
    0
        Minor
    0
        Adults
    0
    Age continuous
    The age ranged from 12.0 to 29.0 years (19.2 ± 4.27) with 15 adults (60.0%) and 10 minors (40.0%).
    Units: years
        median (standard deviation)
    18 ( 4.27 )
    Gender categorical
    As per protocol, females were enrolled only if adults (≥ 18 years old).
    Units: Subjects
        Female
    12
        Male
    13
    IGA scores
    Investigator Global Assessment
    Units: Subjects
        Mild
    10
        Moderate
    10
        Severe
    5

    End points

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    End points reporting groups
    Reporting group title
    SIngle arm (open label study)
    Reporting group description
    		 N-ACETYL-GED-0507-34-LEVO GEL 5%

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population: subjects who took at least one dose of investigational product and had at least one post-dose safety assessment.

    Primary: Safety endpoint

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    End point title
    		 Safety endpoint [1]
    End point description
    The primary objective of the study was to determine local and systemic safety and tolerability of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to 5% gel in patients with facial acne.
    End point type
    Primary
    End point timeframe
    12 weeks
    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 STATISTIC (FREQUENCY TABLES) IS PROVIDED
    End point values
    		 SIngle arm (open label study) Safety population
    Number of subjects analysed
    25
    25
    Units: TEAEs related to study drug
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall
    Adverse event reporting additional description
    30 adverse events, which occurred in 19 subjects (76.0%), were registered during the study. In detail, 5 events in 3 subjects with severe IGA, 12 events in 8 subjects with moderate IGA, and 13 events in 8 subjects with mild IGA. All of them were resolved. No SAEs were reported during the study.No AE lead to permanent discontinuation of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Summary AE
    Reporting group description
    		 Characteristics and description of adverse events occurred during the study are listed in Table XIII. Thirty (30) adverse events, which occurred in 19 subjects (76.0%), were registered during the study. In detail, 5 events in 3 subjects with severe IGA, 12 events in 8 subjects with moderate IGA, and 13 events in 8 subjects with mild IGA. All of them were resolved. As about the severity of the event, 19 (63.3%) were considered of mild intensity, 9 (30.0%) moderate, and 2 (6.7%) severe. Three (3) events occurred in 2 patients with mild IGA were judged possible related to study treatment. No SAEs were reported during the study. No AE lead to permanent discontinuation of study treatment.

    Serious adverse events
    		 Summary AE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Summary AE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 25 (76.00%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Application site drynes
         subjects affected / exposed
    6 / 25 (24.00%)
         occurrences all number
    6
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    4

    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.
    in the interpretation of the results the main limits of this study must be considered: a) open study design; b) absence of control group; c) relatively small size of the three study groups; d) study duration limited to 12 weeks.
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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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