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

NCT02932267 | Completed Phase 3 Results FDA Drug

• 1 other identifier: RD.03.SPR.110232
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 3

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).

Conditions

Acne Vulgaris

Keywords

Acne; Dark skin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adapalene / BPO gel

EXPERIMENTAL

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

Drug: Adapalene 0.3% / BPO 2.5% gel

Interventions

Adapalene 0.3% / BPO 2.5% gel DRUG

Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Also known as: Epiduo Forte / Tactupump gel

Adapalene / BPO gel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Dermresearch

Austin, Texas, 78759, United States

Location

CIDP

Phoenix, Mauritius

Location

CIDP

Singapore, Singapore

Location

Related Publications (1)

• DuBois J, Ong GCW, Petkar G, Almeida LMC, Chavda R, Kerrouche N, Alexis AF. Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study. J Drugs Dermatol. 2019 Jun 1;18(5):514.

  PMID: 31251543 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Gels; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Drug Combinations

Results Point of Contact

• Title: Rajeev Chavda
• Organization: Galderma

rajeev.chavda@galderma.com

0033

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 13, 2016
• Study Start: February 2, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: February 18, 2021
• Results First Posted: November 15, 2019

Record last verified: 2019-12

Locations

US (1); SG (1); MA (1)