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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02735421
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Information provided by (Responsible Party):

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
Drug Information available for: Adapalene

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Subject with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:

    1. Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
    2. A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
    3. No more than two acne nodules (≥ 1 cm); and
    4. A minimum of 10 atrophic acne scars in total (upper than 2 mm) (excluding the nose).
  • Subject with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face
  • Subject with skin phototype of I to IV on Fitzpatrick's scale

Main Exclusion Criteria:

  • Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment.
  • Prior failure to treatment with TactuPump® Forte (Adapalene 0.3% - BPO 2.5%).
  • Subject with more than 3 excoriated acne lesions.
  • Subject with skin abraded on the treated area or affected by eczema, seborrhoeic dermatitis, cuts or sunburn.
  • Female subject who is pregnant, nursing or planning a pregnancy during the trial or within one month after the last trial treatment application
  • Male subject with a beard or facial hair, which would interfere with the clinical trial evaluations or clinical trial procedures
  • Subject having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, antibacterials, antiseptics, other anti-inflammatory drugs or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Photodynamic therapy, laser therapy, microdermabrasion for acne (3 months)
  • Subject having received at least one of the following systemic treatments: Corticosteroids (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), antibiotics (except penicillin) (1 month); Spironolactone (3 months) / Drospirenone (3 months, unless dose is stable since at least 3 months); Oral retinoids (6 months); Cyproterone acetate / Chlormadinone acetate (6 months); Immunomodulators (3 months)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02735421

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Canada, Ontario
Markham, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Saint Jérôme, Quebec, Canada
Nantes, France
Sponsors and Collaborators
  Study Documents (Full-Text)

Documents provided by Galderma:
Study Protocol  [PDF] July 6, 2016
Statistical Analysis Plan  [PDF] June 27, 2017

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Galderma Identifier: NCT02735421    
Other Study ID Numbers: RD.03.SPR.105061
First Posted: April 12, 2016    Key Record Dates
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019
Last Verified: November 2019
Keywords provided by Galderma:
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pathological Conditions, Anatomical
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents