title: A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea.
abstract: Rosacea is a chronic relapsing skin disorder primarily affecting the face. Although its etiology is not well defined, rosacea is associated with immune dysregulation and inflammation potentiated by external factors. These manifestations lead to skin sensitivity and impaired quality of life. Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation. This phase 3 study evaluated the efficacy and safety of AzA in a 15% foam formulation for the treatment of papulopustular rosacea (PPR). Coprimary efficacy end points were treatment success according to investigator global assessment (IGA) and the nominal change in inflammatory lesion count (ILC) from baseline to the end of treatment (EoT). Adverse events (AEs) were evaluated as a measure of safety. The IGA success rate at EoT was significantly greater in the AzA foam group versus vehicle (P<.001; Cochran-Mantel-Haenszel test). Likewise, nominal ILC change at EoT in the AzA foam group showed a significantly greater decrease versus vehicle (P<.001; F test). Drug-related AEs were mainly mild to moderate, cutaneous, and local. Overall, the study results support the efficacy and safety of twice-daily AzA foam 15% in patients with PPR.
authors.affiliation: 2444 N Main St, High Point, NC 27262, USA. zdraelos@northstate.net.
authors.forename: Zoe Diana
authors.initials: ZD
authors.lastname: Draelos
authors.forename: Boni E
authors.initials: BE
authors.lastname: Elewski
authors.forename: Julie C
authors.initials: JC
authors.lastname: Harper
authors.forename: Meike
authors.initials: M
authors.lastname: Sand
authors.forename: Gerald
authors.initials: G
authors.lastname: Staedtler
authors.forename: Richard
authors.initials: R
authors.lastname: Nkulikiyinka
authors.forename: Kaweh
authors.initials: K
authors.lastname: Shakery
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003998:Dicarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012393:Rosacea / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; C010038:azelaic acid