title: 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.affiliation: Henry Ford Health System, Detroit, Michigan 48202, USA. lstein1@hfhs.org
authors.forename: Linda Stein
authors.initials: LS
authors.lastname: Gold
authors.forename: Alma
authors.initials: A
authors.lastname: Cruz
authors.forename: Lawrence
authors.initials: L
authors.lastname: Eichenfield
authors.forename: Jerry
authors.initials: J
authors.lastname: Tan
authors.forename: Joseph
authors.initials: J
authors.lastname: Jorizzo
authors.forename: Nabil
authors.initials: N
authors.lastname: Kerrouche
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Dhuin
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001585:Benzoyl Peroxide / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D009281:Naphthalenes; D014677:Pharmaceutical Vehicles; D000068816:Adapalene; D004318:Doxycycline; D001585:Benzoyl Peroxide