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

Acne Vulgaris Clinical Trial

— EDeN  

Official title:

Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932267
• Other study ID #: RD.03.SPR.110232
• Status: Completed
• Phase: Phase 3
• Start date: February 2, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: December 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene 0.3% / BPO 2.5% gel
Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Locations

Country	Name	City	State
Mauritius	CIDP	Phoenix
Singapore	CIDP	Singapore
United States	Dermresearch	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Mauritius,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire	% of subjects satisfied to very satisfied with study treatment at week 12	At week 12