Effective and safe combination therapy for severe acne vulgaris: a randomized, vehicle-controlled, double-blind study of adapalene 0.1%-benzoyl peroxide 2.5% fixed-dose combination gel with doxycycline hyclate 100 mg.

Abstract

There is a paucity of treatment options for severe acne vulgaris aside from oral isotretinoin. This randomized, vehicle-controlled, multicenter, double-blind study evaluated the efficacy and safety of combination therapy using adapalene 0.1%-benzoyl peroxide 2.5% (A/BPO) fixed-dose combination gel with doxycycline hyclate 100 mg in the treatment of severe acne vulgaris. A total of 459 participants were randomized in a 1:1 ratio to receive oral doxycycline hyclate 100 mg once daily and either A/BPO or vehicle once daily for 12 weeks. Efficacy in the A/BPO with doxycycline group was demonstrated as early as week 2 compared with the vehicle arm for total, inflammatory, and noninflammatory lesions (all P < .005). At week 12, this combination was superior to vehicle with doxycycline in reducing total, inflammatory, and noninflammatory lesion counts (an added incremental benefit of 23%, 24%, and 21%, respectively), as well as for global success and overall participant satisfaction (all P < .001). Digital UV fluorescence photography demonstrated a rapid reduction in Propionibacterium acnes in the A/BPO with doxycycline group, particularly within the first 4 weeks. These findings provide evidence on the efficacy of combining A/BPO and the oral antibiotic doxycycline in the treatment of severe acne vulgaris.

• Authors: Linda Stein Gold, Alma Cruz, Lawrence Eichenfield, Jerry Tan, Joseph Jorizzo, Nabil Kerrouche, Jean-Charles Dhuin
• Journal: Cutis (Cutis) Vol. 85 Issue 2 Pg. 94-104 (Feb 2010) ISSN: 0011-4162 [Print] United States
• PMID: 20349684 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Anti-Inflammatory Agents, Non-Steroidal
• Dermatologic Agents
• Drug Combinations
• Gels
• Naphthalenes
• Pharmaceutical Vehicles
• Adapalene
• Doxycycline
• Benzoyl Peroxide

Topics

• Acne Vulgaris (drug therapy)
• Adapalene
• Administration, Oral
• Administration, Topical
• Adolescent
• Anti-Bacterial Agents (administration & dosage, adverse effects)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Benzoyl Peroxide (administration & dosage, adverse effects)
• Dermatologic Agents (administration & dosage, adverse effects)
• Double-Blind Method
• Doxycycline (administration & dosage, adverse effects, analogs & derivatives)
• Drug Combinations
• Female
• Gels
• Humans
• Male
• Naphthalenes (administration & dosage, adverse effects)
• Pharmaceutical Vehicles (administration & dosage)