title: Azelaic acid foam 15% in the treatment of papulopustular rosacea: a randomized, double-blind, vehicle-controlled study.
abstract: Rosacea is a common chronic inflammatory skin disease that primarily affects facial skin. Its etiology is unknown, and currently there is no cure. Rosacea can be associated with severe symptoms, including transient erythema (flushing), nontransient erythema, papules, pustules, and telangiectases, leading to substantial discomfort and an unattractive appearance. This randomized, double-blind, vehicle-controlled, multicenter, parallel-group study conducted over 12 weeks with a 4-week follow-up period evaluated the efficacy and safety of a new formulation of azelaic acid (AzA) foam in a 15% concentration compared to vehicle alone in patients with papulopustular rosacea (PPR). Primary efficacy variables assessed were investigator global assessment (IGA) dichotomized into success and failure, and nominal change in inflammatory lesion count from baseline to end of treatment. Results indicated that the new foam formulation of AzA is effective and well-tolerated in a population of patients with PPR. Although no single formulation is appropriate for all patients, the development of a new foam formulation in addition to other available vehicles provides patients with options and allows health care providers to match the needs as well as preferences of individual patients and skin types with appropriate delivery modalities.
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
authors.initials: B
authors.lastname: Elewski
authors.forename: Gerald
authors.initials: G
authors.lastname: Staedtler
authors.forename: Blanka
authors.initials: B
authors.lastname: Havlickova
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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; D012393:Rosacea / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; C010038:azelaic acid