Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Condition: Acne Vulgaris; Atrophic Acne Scars
MeSH terms: Acne Vulgaris; Atrophy
Intervention: ABPO Forte Gel; Vehicle gel
Intervention description: 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.; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: acne; scars

Summary:

      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.
    

Eligibility 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).