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
This is a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).
Subjects will have each half-face randomized to one of the two following treatments:
- Adapalene 0.3% - BPO 2.5% gel (TactuPump® Forte).
- Vehicle gel
The main objective of this trial is to evaluate the effect of Adapalene 0.3% - benzoyl peroxide (BPO) 2.5% gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne subjects.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris Atrophic Acne Scars||Drug: Adapalene 0.3% / BPO 2.5% gel Drug: Vehicle gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects|
|Actual Study Start Date :||May 13, 2016|
|Actual Primary Completion Date :||June 5, 2017|
|Actual Study Completion Date :||November 23, 2017|
Experimental: Adapalene / BPO gel
Adapalene 0.3% / BPO 2.5% gel, once daily in the evening on half of the face (determined by randomization)
Drug: Adapalene 0.3% / BPO 2.5% gel
Other Name: TactuPump Forte
Placebo Comparator: Vehicle gel
Vehicle gel, once daily in the evening on half of the face (determined by randomization)
Drug: Vehicle gel
- Total Atrophic Acne Scar Count Per Half-face [ Time Frame: Week 24 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735421
|Markham, Ontario, Canada|
|Oakville, Ontario, Canada|
|Toronto, Ontario, Canada|
|Windsor, Ontario, Canada|
|Montreal, Quebec, Canada|
|Saint Jérôme, Quebec, Canada|