Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study
| Autor: | Alicia D. Bucko, Lawrence F. Eichenfield, Sewon Kang, Yin Liu, Jonathan S. Weiss, Terry M. Jones, Scott D Clark, Diane Thiboutot, Michael Graeber |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization Adolescent Adapalene/benzoyl peroxide Fixed-dose combination Dermatology Benzoyl peroxide Naphthalenes law.invention Randomized controlled trial Double-Blind Method Adapalene law Acne Vulgaris medicine Humans Child Acne Benzoyl Peroxide business.industry Middle Aged medicine.disease Drug Combinations Treatment Outcome Tolerability Female Dermatologic Agents business medicine.drug |
| Zdroj: | Journal of the American Academy of Dermatology. 57(5) |
| ISSN: | 1097-6787 |
| Popis: | Background A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for the once-daily treatment of acne. Objective To evaluate the efficacy and safety of adapalene 0.1% -BPO 2.5% fixed combination gel (adapalene-BPO) for the treatment of acne. Methods A total of 517 subjects were randomized in a double-blind controlled trial to receive either adapalene-BPO, adapalene, BPO, or vehicle for 12 weeks (2:2:2:1 randomization). Evaluation included success rate (subjects "clear" or "almost clear"), lesion count, cutaneous tolerability, and adverse events. Results The fixed-dose combination gel of adapalene and BPO was significantly more effective than corresponding monotherapies, with significant differences in total lesion counts observed as early as 1 week. Adverse event frequency and cutaneous tolerability profile for adapalene-BPO were similar to adapalene monotherapy. Limitations These data were generated in a controlled trial. Results obtained in clinical practice could differ. Conclusions The fixed-dose combination of adapalene and BPO provides significantly greater efficacy for the treatment of acne vulgaris as early as week 1 relative to monotherapies, with a comparable safety profile to adapalene. |
| Databáze: | OpenAIRE |
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