Phase 4
N=67
Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Acne Vulgaris · Atrophic Acne Scars
Bottom Line
View on ClinicalTrials.gov: NCT02735421 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Part 1: Total Atrophic Acne Scar Count Per Half-face — 9.5; 13.3 atrophic acne scars — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ABPO Forte Gel (Drug); Vehicle gel (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Total Atrophic Acne Scar Count Per Half-face |
9.5; 13.3 | <0.0001 sig |
| SECONDARY Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit |
11.7; 12.8; 12.2; 13.1; 11.9; 13.6 | — |
| SECONDARY Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit |
-2.5; 5.8; -2.6; 6.6; -1.0; 9.8 | — |
| SECONDARY Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score |
2.3; 2.3; 2.3; 2.3; 2.2; 2.3 | — |
| SECONDARY Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity |
5.1; 33.9; 17.5; 36.5 | — |
| SECONDARY Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit |
-20.9; -5.7; -23.4; -7.6; -34.1; -13.1 | — |
| SECONDARY Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit |
-28.0; -10.4; -29.2; -11.9; -43.5; -19.8 | — |
| SECONDARY Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit |
-9.2; 0.3; -10.7; -2.7; -20.1; -1.5 | — |
| SECONDARY Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit |
2.7; 3.0; 2.7; 3.0; 2.5; 2.8 | — |
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:
- Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
- A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
- No more than two acne nodules (less than or equal to [>=] 1 centimeter [cm]); and
- 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).
Data sourced from ClinicalTrials.gov (NCT02735421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.