RD.03.SPR.105061

About this trial

Last updated 3 years ago

Study ID

RD.03.SPR.105061

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

16 to 35 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

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.

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).

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