title: Patient-reported outcomes of azelaic acid foam 15% for patients with papulopustular rosacea: secondary efficacy results from a randomized, controlled, double-blind, phase 3 trial.
abstract: Patient-reported treatment outcomes are important for evaluating the impact of drug therapies on patient experience. A randomized, double-blind, vehicle-controlled, parallel-group, multicenter, phase 3 study was conducted in 961 participants to assess patient perception of efficacy, utility, and effect on quality of life (QOL) of an azelaic acid (AzA) 15% foam formulation for the treatment of papulopustular rosacea (PPR). Secondary end points included patient-reported global assessment of treatment response, global assessment of tolerability, and opinion on cosmetic acceptability and practicability of product use. Quality of life assessments included the Dermatology Quality of Life Index (DLQI) and Rosacea Quality of Life Index (RosaQOL). Self-reported global assessment of treatment response favored AzA foam over vehicle foam (P<.001), with 57.2% of the AzA foam group reporting excellent or good improvement versus 44.7% in the vehicle foam group. Tolerability was rated excellent or good in 67.8% of the AzA foam group versus 78.2% of the vehicle foam group. Mean overall DLQI scores at end of treatment (EoT) were improved (P=.018) in favor of the AzA foam group compared with the vehicle foam group. Both treatment groups showed improvements in RosaQOL. Treatment with AzA foam was associated with improved QOL and meaningful reductions in the patient-perceived burden of PPR, which correlates with earlier reported primary end points of this study and supports the inclusion of patient perspectives in studies evaluating the effects of topical dermatologic treatments.
authors.affiliation: Department of Dermatology, University of Texas Health Science Center, Houston, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Tyring
authors.affiliation: Ameriderm Research, Ormond Beach, Florida, USA.
authors.forename: James A
authors.initials: JA
authors.lastname: Solomon
authors.affiliation: Bayer Pharmaceuticals, Berlin, Germany.
authors.forename: Gerald
authors.initials: G
authors.lastname: Staedtler
authors.affiliation: Bayer Pharmaceuticals, Whippany, New Jersey, USA.
authors.forename: Jason P
authors.initials: JP
authors.lastname: Lott
authors.affiliation: Bayer Pharmaceuticals, Berlin, Germany.
authors.forename: Richard
authors.initials: R
authors.lastname: Nkulikiyinka
authors.affiliation: Bayer Pharmaceuticals, Berlin, Germany.
authors.forename: Kaweh
authors.initials: K
authors.lastname: Shakery
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003879:Dermatologic Agents / Q000627:therapeutic use*; D003998:Dicarboxylic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D012393:Rosacea / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; C010038:azelaic acid