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

• Status: Completed
• Trial end date: 2017-11-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene; Benzoyl Peroxide

Criteria

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)