Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: Results of a multicenter, randomized double-blind, controlled study

• Published in: Journal of the American Academy of Dermatology Vol. 57; no. 5; pp. 791 - 799
• Main Authors: Thiboutot, Diane M., Weiss, Jonathan, Bucko, Alicia, Eichenfield, Lawrence, Jones, Terry, Clark, Scott, Liu, Yin, Graeber, Michael, Kang, Sewon
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.11.2007; Elsevier
• Subjects: Acne Vulgaris - drug therapy; Adapalene; Adolescent; Adult; Benzoyl Peroxide - adverse effects; Benzoyl Peroxide - therapeutic use; Biological and medical sciences; Child; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Dermatology; Double-Blind Method; Drug Combinations; Female; Humans; Male; Medical sciences; Middle Aged; Naphthalenes - adverse effects; Naphthalenes - therapeutic use; Skin involvement in other diseases. Miscellaneous. General aspects; Treatment Outcome; BPO; PP; ITT; IGA; LOCF; investigator's global assessment; last observation carried forward; per-protocol; benzoyl peroxide; intention-to-treat; Acne vulgaris; Skin disease; Treatment; Adapalene; Dermatology; Retinoid; Double blind study; Antiacneic agent; Benzoyl peroxide; Dose
• ISSN: 0190-9622; 1097-6787; 1097-6787
• DOI: 10.1016/j.jaad.2007.06.006

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. To evaluate the efficacy and safety of adapalene 0.1% -BPO 2.5% fixed combination gel (adapalene-BPO) for the treatment of acne. 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. 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. These data were generated in a controlled trial. Results obtained in clinical practice could differ. 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.