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

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

This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Participants with each half-face randomized to one of the two following treatments:

• Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).
• Vehicle gel

The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris; Atrophic Acne Scars
• Intervention / Treatment: Drug: ABPO Forte Gel; Drug: Vehicle gel

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada
    • Oakville, Ontario, Canada
    • Toronto, Ontario, Canada
    • Windsor, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Saint Jérôme, Quebec, Canada
• France
  • Nantes, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 33 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Participants 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 (less than or equal to [>=] 1 centimeter [cm]); and
  4. A minimum of 10 atrophic acne scars in total (upper than 2 millimeters [mm]) (excluding the nose)
• Participants with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face.
• Participants with skin phototype of I to IV on Fitzpatrick's scale.

Main Exclusion Criteria:

• Participants 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%).
• Participants with more than 3 excoriated acne lesions.
• Participants with skin abraded on the treated area or affected by eczema, seborrhoeic dermatitis, cuts or sunburn.
• Female participant who is pregnant, nursing or planning a pregnancy during the trial or within one month after the last trial treatment application.
• Male participant with a beard or facial hair, which would interfere with the clinical trial evaluations or clinical trial procedures.
• Participants 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).
• Participants 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: ABPO Forte Gel	Drug: ABPO Forte Gel; Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.; Other Names: TactuPump Forte
Placebo Comparator: Part 1: ABPO Forte Vehicle Gel	Drug: Vehicle gel; Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2.
Experimental: Part 2: ABPO Forte Gel	Drug: ABPO Forte Gel; Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.; Other Names: TactuPump Forte
Placebo Comparator: Part 2: ABPO Forte Vehicle Gel	Drug: Vehicle gel; Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Total Atrophic Acne Scar Count Per Half-face	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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit	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.	Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit	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.	Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score	ISGA was an assessment scale used to evaluate facial acne severity. ISGA was recorded using a 5-point scale ranges from 0 to 4, where (0 = clear [No visible scars from acne); 1 = almost clear [Hardly visible scars from 50 cm away]; 2 = mild [Easily recognizable; less than half the affected face area]; 3 = moderate [More than half and less than 75% of the affected face area]; 4 = severe [More than 75% of the affected face area]) based on inflammation, pustules and papulation/infiltration. Higher score indicated severe acne.	Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity	The investigator rated their preference on a scale ranging from -2 (left side a lot better than right) to 2 (right side a lot better than left). Overall scar severity was assessed using a 5-point scale where (-2 = Left a lot better than right; -1 = Left a little bit better than right; 0 = No preference; 1 = Right a little bit better than left; 2 = Right a lot better than left. ABPO forte was applied on left side and vehicle gel was applied on right side.	At Week 12 and Week 24
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit	Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and other lesions. The investigator counted all inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedone) and other lesions (nodules) for each half-face.	Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit	Inflammatory lesions included papules and pustules. Papule is a small, solid elevation less than one centimeter in diameter. Most of the lesion is above the surface of the skin. Pustule is a small, circumscribed elevation of the skin which contains yellow-white exudates.	Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit	Non-inflammatory lesions included open comedone and closed comedone. Open comedone is a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead). Closed comedone is a mass of sebaceous material that is impacted behind a closed follicular orifice (white head).	Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit	IGA is an assessment scale used to determine severity of acne and clinical response to treatment on a 5-point scale (0 = clear [Clear skin with no inflammatory or non inflammatory lesions]; 1= almost clear [A few scattered comedones and a few small papules]; 2= mild [Easily recognizable; less than half the face is involved. Some comedones and some papules and pustules]; 3= moderate [More than half of the face is involved. Many comedones, papules and pustules. One small nodule may be present] and 4= severe [Entire face is involved. Covered with comedones, numerous papules and pustules. Few nodules may or may not be present]) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).	Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48

Collaborators and Investigators

• Sponsor: Galderma R&D

Publications and helpful links

General Publications

• Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.
• Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2016
• Primary Completion (Actual): June 5, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: acne; scars
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Atrophy
• Other Study ID Numbers: RD.03.SPR.105061; 2016-002666-31 (EudraCT Number)