Clinical trial NCT02735421: Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Atrophic Acne Scars
Keywords: acne
scars
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-04-12
Enrollment: 67
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

Primary outcomes:
measure: Part 1: Total Atrophic Acne Scar Count Per Half-face
timeFrame: Week 24
Secondary outcomes:
measure: Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48
measure: Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
measure: Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
measure: Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
timeFrame: At Week 12 and Week 24
measure: Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48
measure: Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
measure: Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
measure: Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
timeFrame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Other outcomes:
Locations:
city: Markham
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saint Jérôme
country: Canada
state: Quebec
city: Nantes
country: France
Study officials:
References:
citation: Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.
citation: Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.