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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT02735421
• Date of registration: 07/04/2016
• Prospective Registration: Yes
• Primary sponsor: Galderma R&D
• Public title: Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars OSCAR
• Scientific 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
• Date of first enrolment: May 13, 2016
• Target sample size: 67
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02735421
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

Canada, France

Key inclusion & exclusion 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)



Age minimum: 16 Years
Age maximum: 35 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Atrophic Acne Scars

Intervention(s)

Drug: Adapalene 0.3% / BPO 2.5% gel

Drug: Vehicle gel

Primary Outcome(s)

Total Atrophic Acne Scar Count Per Half-face [Time Frame: Week 24]

Secondary ID(s)

RD.03.SPR.105061

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02735421