Phase 3
N=50
Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02932267 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire — 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adapalene 0.3% / BPO 2.5% gel (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire |
36 | — |
Summary
This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.
All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.
The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).
Eligibility Criteria
Inclusion Criteria
- Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
- Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and
- A minimum of 25-100 inflammatory lesions (papules and pustules); and
- A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
- No more than two acne nodules (≥ 1 cm),
- Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale,
- Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,
Exclusion Criteria
- Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment,
- Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea
- Female subject who is pregnant, lactating or planning a pregnancy during the trial,
- Subjects having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxyacids, Zinc containing treatments, antiseptics, other anti-inflammatory products or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Wax epilation (2 weeks); Photodynamic therapy (6 weeks); Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne (3 months).
- Subjects having received at least one of the following systemic treatments: Corticosteroids, tetracyclines, other antibiotics (except penicillin) (1 month); Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / Chlormadinone acetate (6 months); Spironolactone/ Drospirenone (3 months); Immunomodulators (3 months) and Oral contraceptives/ oral dapsone for acne(1 month).
Data sourced from ClinicalTrials.gov (NCT02932267). 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.