title: Short-term combination therapy and long-term relapse prevention in the treatment of severe acne vulgaris.
abstract: Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects.
authors.affiliation: Windsor Clinical Research Inc., Windsor, Ontario, Canada. jerrytan@bellnet.ca
authors.forename: Jerry
authors.initials: J
authors.lastname: Tan
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
authors.forename: Joel
authors.initials: J
authors.lastname: Schlessinger
authors.forename: Robert
authors.initials: R
authors.lastname: Brodell
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Alma
authors.initials: A
authors.lastname: Cruz
authors.forename: Nabil
authors.initials: N
authors.lastname: Kerrouche
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology*; D000068816:Adapalene; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage*; D055502:Secondary Prevention; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009281:Naphthalenes; D000068816:Adapalene; D004318:Doxycycline; D001585:Benzoyl Peroxide