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Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars (OSCAR)

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ClinicalTrials.gov Identifier: NCT02735421
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Conditions Acne Vulgaris
Atrophic Acne Scars
Interventions Drug: Adapalene 0.3% / BPO 2.5% gel
Drug: Vehicle gel
Enrollment 67
Recruitment Details  
Pre-assignment Details A total of 67 Participants were randomized. All eligible participants had each half-face randomized to one of the two following treatments (with the other treatment applied to the other side of the face): adapalene 0.3% - benzoyl peroxide (BPO) 2.5% gel and adapalene 0.3% - BPO 2.5% vehicle gel.
Arm/Group Title All Participants
Hide Arm/Group Description Participants applied once-daily adapalene 0.3% - BPO 2.5% gel on half-face and adapalene 0.3% - BPO 2.5% vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks.
Period Title: Overall Study
Started 67
Completed 54
Not Completed 13
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             6
Lost to Follow-up             3
Inadequate compliance to treatment             1
Pregnancy             1
Arm/Group Title All Participants
Hide Arm/Group Description Participants applied once-daily adapalene 0.3% - BPO 2.5% gel on half-face and adapalene 0.3% - BPO 2.5% vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks.
Overall Number of Baseline Participants 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
<=18 years
19
  28.4%
Between 18 and 65 years
48
  71.6%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants
21.5  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Female
44
  65.7%
Male
23
  34.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
American Indian or Alaska Native
0
   0.0%
Asian
9
  13.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
58
  86.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants
Canada 48
France 19
Skin Phototype   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Phototype I
3
   4.5%
Phototype II
32
  47.8%
Phototype III
23
  34.3%
Phototype IV
9
  13.4%
[1]
Measure Description: Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to VI. Where, skin phototype I = pale white skin, blue/green eyes, blond/red hair, always burns, does not tan; skin phototype II = fair skin, blue eyes; burns easily, tans poorly; skin phototype III = darker white skin, tans after initial burn; skin phototype IV = light brown skin, burns minimally, tans easily; skin phototype V = brown skin, rarely burns, tans darkly easily; skin phototype VI = dark brown or black skin, never burns, always tans darkly.
Acne Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants
6.8  (4.2)
1.Primary Outcome
Title Total Atrophic Acne Scar Count Per Half-face
Hide 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population
Arm/Group Title Adapalene / BPO Gel Vehicle Gel
Hide Arm/Group Description:
Participants applied once-daily adapalene 0.3% - BPO 2.5% gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
Participants applied once-daily adapalene 0.3% - BPO 2.5% vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: atrophic acne scars
9.5  (5.5) 13.3  (7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene / BPO Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene / BPO Side Vehicle Side Unspecific Treated Side
Hide Arm/Group Description On the side treated with Adapalene 0.3% / BPO 2.5% gel, once daily in the evening on half of the face (determined by randomization). On the side treated with Vehicle gel, once daily in the evening on half of the face (determined by randomization). Unspecific treated site.
All-Cause Mortality
Adapalene / BPO Side Vehicle Side Unspecific Treated Side
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)      0/67 (0.00%)      0/67 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene / BPO Side Vehicle Side Unspecific Treated Side
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      0/67 (0.00%)      0/67 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Adapalene / BPO Side Vehicle Side Unspecific Treated Side
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/67 (16.42%)      5/67 (7.46%)      42/67 (62.69%)    
Eye disorders       
Eyelid irritation  1  0/67 (0.00%)  0 0/67 (0.00%)  0 3/67 (4.48%)  3
Gastrointestinal disorders       
Abdominal pain  1  0/67 (0.00%)  0 0/67 (0.00%)  0 3/67 (4.48%)  4
Infections and infestations       
Influenza  1  0/67 (0.00%)  0 0/67 (0.00%)  0 5/67 (7.46%)  7
Nasopharyngitis  1  0/67 (0.00%)  0 0/67 (0.00%)  0 17/67 (25.37%)  20
Nervous system disorders       
Headache  1  0/67 (0.00%)  0 0/67 (0.00%)  0 17/67 (25.37%)  23
Skin and subcutaneous tissue disorders       
Skin irritation  1  11/67 (16.42%)  11 5/67 (7.46%)  5 1/67 (1.49%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gaëlle CHARIER Clinical Project Manager
Organization: Galderma
Phone: +33493957068
EMail: gaelle.charier@galderma.com
Layout table for additonal information
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02735421     History of Changes
Other Study ID Numbers: RD.03.SPR.105061
First Submitted: April 7, 2016
First Posted: April 12, 2016
Results First Submitted: September 4, 2018
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019