Multicenter study for efficacy and safety evaluation of a fixeddose combination gel with adapalen 0.1% and benzoyl peroxide 2.5% (Epiduo® for the treatment of acne vulgaris in Brazilian population* * Study performed at Hospital do Servidor Público Estadual de São Paulo (HSPE); KOLderma Instituto de Pesquisa Clínica Ltda.; Pontifícia Universidade Católica de Campinas; Hospital De Clínicas - Universidade Federal do Paraná (UFPA); Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia; Instituto de Dermatologia e Estética do Brasil Ltda. (IDERJ); Instituto da Pele, Goiânia/ GO.

José Alexandre de Souza Sittart Adilson da Costa Fabiane Mulinari-Brenner Ivonise Follador Luna Azulay-Abulafia Lia Cândida Miranda de Castro About the authors

Abstract:

BACKGROUND:

The current options for the treatment of acne vulgaris present many mechanisms of action. For several times, dermatologists try topical agents combinations, looking for better results.

OBJECTIVES:

To evaluate the efficacy, tolerability and safety of a topical, fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel for the treatment of acne vulgaris in the Brazilian population.

METHODS:

This is a multicenter, open-label and interventionist study. Patients applied 1.0 g of the fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel on the face, once daily at bedtime, during 12 weeks. Lesions were counted in all of the appointments, and the degree of acne severity, overall improvement, tolerability and safety were evaluated in each visit.

RESULTS:

From 79 recruited patients, 73 concluded the study. There was significant, fast and progressive reduction of non-inflammatory, inflammatory and total number of lesions. At the end of the study, 75.3% of patients had a reduction of >50% in non-inflammatory lesions, 69.9% in inflammatory lesions and 78.1% in total number of lesions. Of the 73 patients, 71.2% had good to excellent response and 87.6% had satisfactory to good response. In the first week of treatment, erythema, burning, scaling and dryness of the skin were frequent complaints, but, from second week on, these signals and symptoms have reduced.

CONCLUSION:

The fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel is effective, safe, well tolerated and apparently improves patient compliance with the treatment.

Keywords:
Acne vulgaris; Benzoyl peroxide; Combined modality therapy; Dermatology; Drug therapy, combination; Multicenter Study; Propionibacterium acnes; Skin diseases; Treatment outcome

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