Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene 0.3% / BPO 2.5% gel

• Registration Number: NCT02932267
• Lead Sponsor: Galderma R&D

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Study Start: 2017-02-02
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Results First Submitted: 2018-09-26
• Results First Submitted QC: 2019-11-11
• Results First Posted: 2019-11-15
• Status Verified: 2019-12
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:

  1. Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and
  2. A minimum of 25-100 inflammatory lesions (papules and pustules); and
  3. A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
  4. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adapalene / BPO gel	Adapalene 0.3% / BPO 2.5% gel	Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Primary Outcome Measures

Name	Time	Method
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire	At week 12	% of subjects satisfied to very satisfied with study treatment at week 12

Trial Locations

Locations (2)

Dermresearch; 🇺🇸 Austin, Texas, United States

CIDP; 🇸🇬 Singapore, Singapore