title: Efficacy and tolerance of adapalene cream 0.1% compared with its cream vehicle for the treatment of acne vulgaris.
abstract: Adapalene gel 0.1% is approved for use in the treatment of acne vulgaris. A new cream formulation, adapalene cream 0.1%, has been developed. Our objective was to evaluate the efficacy and tolerability of adapalene cream 0.1% in comparison with its cream vehicle, applied once daily for 12 weeks to patients with facial acne vulgaris. We used a 12-week, multicenter, randomized, double-blind, vehicle-controlled, comparative phase 3 study of adapalene cream 0.1% and cream vehicle. The study enrolled 237 patients (125 males and 112 females), aged 12 through 30 years, with mild-to-moderate acne vulgaris. Adapalene cream 0.1% demonstrated superior efficacy compared with its cream vehicle. Significantly lower numbers of total inflammatory and noninflammatory lesion counts were observed at the end of the study period in patients using adapalene cream 0.1% as opposed to those using cream vehicle (P<.05 compared with baseline, for all 3 parameters). Adapalene cream 0.1% caused more cutaneous side effects than the cream vehicle, but these were tolerated in most patients. In summary, the results of this study indicate that adapalene cream 0.1% demonstrates superior efficacy over cream vehicle for the treatment of acne vulgaris. Adapalene cream 0.1% also has excellent tolerability and is associated with a low incidence of cutaneous adverse events.
authors.affiliation: Dermatology Research Associates, Cincinnati, Ohio, USA.
authors.forename: A
authors.initials: A
authors.lastname: Lucky
authors.forename: J L
authors.initials: JL
authors.lastname: Jorizzo
authors.forename: D
authors.initials: D
authors.lastname: Rodriguez
authors.forename: T M
authors.initials: TM
authors.lastname: Jones
authors.forename: D M
authors.initials: DM
authors.lastname: Stewart
authors.forename: E H
authors.initials: EH
authors.lastname: Tschen
authors.forename: N B
authors.initials: NB
authors.lastname: Kanof
authors.forename: B H
authors.initials: BH
authors.lastname: Miller
authors.forename: D C
authors.initials: DC
authors.lastname: Wilson
authors.forename: K H
authors.initials: KH
authors.lastname: Loven
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002648:Child; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000627:therapeutic use*; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D009281:Naphthalenes; D014677:Pharmaceutical Vehicles; D000068816:Adapalene