Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 mcg/g Cream Versus Vehicle Cream Over 24 Weeks

    Summary
    EudraCT number
    		 2020-006050-51
    Trial protocol
    		 FR  
    Global end of trial date
    09 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2024
    First version publication date
    05 Apr 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RD.06.SPR.202395
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04856904
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma S.A.
    Sponsor organisation address
    Zahlerweg 10, 6300 Zug, ZUG, Switzerland, 6300
    Public contact
    Clinical Trial Information Desk, CTD Coordinator Galderma R&D S.A., ctacoordinator@galderma.com
    Scientific contact
    Clinical Trial Information Desk, CTD Coordinator Galderma R&D S.A., ctacoordinator@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
    03 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this clinical study was to evaluate the effect of trifarotene compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne subjects assessed by atrophic acne scars count.
    Protection of trial subjects
    This clinical study was conducted in accordance with the protocol, the Declaration of Helsinki, and the International Conference on Harmonization Good Clinical Practices (ICH GCP), and in compliance with other applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 May 2021
    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
    France: 2
    Country: Number of subjects enrolled
    United States: 110
    Country: Number of subjects enrolled
    Canada: 9
    Worldwide total number of subjects
    121
    EEA total number of subjects
    2
    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)
    19
    Adults (18-64 years)
    102
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 20 sites in the United States, Canada, and France from 26 May 2021 to 9 February 2023.

    Pre-assignment
    Screening details
    		 A total 121 subjects were enrolled in this study. All subjects were randomized (left face versus right face) to apply trifarotene cream and trifarotene vehicle cream for an intra-individual, split-face comparison.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Arm title
    		 All Acne Vulgaris Subjects
    Arm description
    		 All subjects applied a thin layer of trifarotene 50 microgram per gram (mcg/g) cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trifarotene 50mcg/g cream
    Investigational medicinal product code
    CD5789
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects applied a thin layer of trifarotene cream to half of their face topically once daily.

    Investigational medicinal product name
    Trifarotene Vehicle Cream
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily.

    Number of subjects in period 1
    		All Acne Vulgaris Subjects
    Started
    121
    Trifarotene 50mcg/g cream
    121
    Trifarotene Vehicle
    121
    Completed
    99
    Not completed
    22
         Physician decision
    1
         Adverse event, non-fatal
    1
         Non-compliance with study drug
    1
         Lost to follow-up
    4
         Withdrawal by parent/guardian
    1
         Protocol deviation
    1
         Withdrawal by subject
    13

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    All Acne Vulgaris Subjects
    Reporting group description
    		 All subjects applied a thin layer of trifarotene 50 microgram per gram (mcg/g) cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.

    Reporting group values
    		 All Acne Vulgaris Subjects Total
    Number of subjects
    		 121 121
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.9 ( 5.12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 88 88
        Male
    		 33 33
    Ethinicity
    Units: Subjects
        Hispanic or Latino
    		 26 26
        Not Hispanic or Latino
    		 95 95
    Race
    Units: Subjects
        White
    		 97 97
        Black or African American
    		 9 9
        Asian
    		 12 12
        Not Reported
    		 3 3
    Fitzpatrick Skin Type
    Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily
    Units: Subjects
        Type I
    		 7 7
        Type II
    		 43 43
        Type III
    		 31 31
        Type IV
    		 26 26
        Type V
    		 11 11
        Type VI
    		 3 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    All Acne Vulgaris Subjects
    Reporting group description
    		 All subjects applied a thin layer of trifarotene 50 microgram per gram (mcg/g) cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.

    Subject analysis set title
    Trifarotene 50 mcg/g Cream
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects applied a thin layer of trifarotene 50 mcg/g cream to half of their face and topically once daily for up to 24 weeks.

    Subject analysis set title
    Trifarotene vehicle cream
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.

    Primary: Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
    End point description
    The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added. ITT population included all randomized subjects.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Trifarotene 50 mcg/g Cream Trifarotene vehicle cream
    Number of subjects analysed
    121
    121
    Units: atrophic acne scars
        arithmetic mean (standard error)
    -5.9 ( 0.51 )
    -2.7 ( 0.37 )
    Statistical analysis title
    		 Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6

    Secondary: Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half Face up to Week 20

    		 Close Top of page
    End point title
    		 Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half Face up to Week 20
    End point description
    The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars > 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added. ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 20
    End point values
    		 Trifarotene 50 mcg/g Cream Trifarotene vehicle cream
    Number of subjects analysed
    121
    121
    Units: atrophic acne scars
    arithmetic mean (standard error)
        Week 1
    -0.3 ( 0.21 )
    -0.3 ( 0.16 )
        Week 2
    -0.9 ( 0.26 )
    -0.4 ( 0.11 )
        Week 4
    -1.5 ( 0.27 )
    -0.7 ( 0.18 )
        Week 8
    -2.5 ( 0.30 )
    -1.1 ( 0.30 )
        Week 12
    -3.8 ( 0.37 )
    -1.7 ( 0.32 )
        Week 16
    -4.4 ( 0.40 )
    -1.7 ( 0.47 )
        Week 20
    -5.0 ( 0.47 )
    -2.5 ( 0.33 )
    Statistical analysis title
    		 Week 1: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9476
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 2: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0248
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Week 4: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0072
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Week 8: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.35
    Statistical analysis title
    		 Week 12: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41
    Statistical analysis title
    		 Week 16: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 -1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.56
    Statistical analysis title
    		 Week 20: Trifarotene 50 mcg/g, vehicle cream
    Statistical analysis description
    Numbers reflecting in field "Number of subjects included in analysis" below is incorrect and this is due to constraints of the database. Consider the total number of subjects included in the analysis as 121. Each half of the face was analysed separately, thus 242 facial halves were analysed.
    Comparison groups
    Trifarotene 50 mcg/g Cream v Trifarotene vehicle cream
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Student's t-test for paired samples
    Parameter type
    		 Bilateral difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 -1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.53

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From screening up to Week 28
    Adverse event reporting additional description
    The safety (SAF) population included the ITT population subjects who applied the study drug at least once.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    All Acne Vulgaris Subjects
    Reporting group description
    		 All subjects applied a thin layer of trifarotene 50 microgram per gram (mcg/g) cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.

    Serious adverse events
    		 All Acne Vulgaris Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 121 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All Acne Vulgaris Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 121 (27.27%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Arthropod bite
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Skin laceration
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pre syncope
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    General disorders and administration site conditions
    Adverse reaction
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Face oedema
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    2
    Vaccination site pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Food poisoning
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Hyperaesthesia teeth
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Sinus congestion
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Skin tightness
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    3
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Kidney infection
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    COVID-19
         subjects affected / exposed
    10 / 121 (8.26%)
         occurrences all number
    10
    Nasopharyngitis
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2021
    Amendment 1: The protocol was revised to address the following typographical errors for document consistency and clarity.
    09 Jul 2021
    Amendment 2: -SCARS questionnaire sample facial image (all pages) and reference to proper side of face . -Subject Satisfaction questionnaire sample facial image. -Inclusion criteria minimum atrophic acne scar size (>=2mm) -Authorized medications and clarity of final study visit (Week 24). Prohibited Medications/Therapies a. include testosterone supplements for consistency with Exclusion Criterion 12 b. omit restrictions that are not applicable (use of antacids, iron-containing supplements) -Summaries of bilateral difference between treatments can be presented only overall and not by treatment.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 06 01:43:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA