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

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris; Atrophic Acne Scars

Treatments: Drug: Vehicle gel; Drug: ABPO Forte Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02735421

RD.03.SPR.105061

2016-002666-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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67 participants in 4 patient groups, including a placebo group

Part 1: ABPO Forte Gel

Experimental group

Treatment:

Drug: ABPO Forte Gel

Part 1: ABPO Forte Vehicle Gel

Placebo Comparator group

Treatment:

Drug: Vehicle gel

Part 2: ABPO Forte Gel

Experimental group

Treatment:

Drug: ABPO Forte Gel

Part 2: ABPO Forte Vehicle Gel

Placebo Comparator group

Treatment:

Drug: Vehicle gel