title: Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies.
abstract: BACKGROUND
  Treatments for papulopustular rosacea (PPR) are limited.
  
  
  OBJECTIVE
  To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR.
  
  
  METHODS
  Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires.
  
  
  RESULTS
  In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA "clear" or "almost clear"): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P<.001), respectively. Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups, respectively). For all endpoints, starting at week 4 and continuing through week 12, IVM 1% was statistically significantly superior (P<.001). Fewer subjects treated by IVM 1% reported dermatologic AEs, and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle. Significantly more subjects receiving IVM 1% reported having an "excellent" or "good" improvement, along with an improved QoL.
  
  
  CONCLUSIONS
  Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.
authors.forename: Linda
authors.initials: L
authors.lastname: Stein
authors.forename: Leon
authors.initials: L
authors.lastname: Kircik
authors.forename: Joseph
authors.initials: J
authors.lastname: Fowler
authors.forename: Jerry
authors.initials: J
authors.lastname: Tan
authors.forename: Zoe
authors.initials: Z
authors.lastname: Draelos
authors.forename: Alan
authors.initials: A
authors.lastname: Fleischer
authors.forename: Melanie
authors.initials: M
authors.lastname: Appell
authors.forename: Martin
authors.initials: M
authors.lastname: Steinhoff
authors.forename: Charles
authors.initials: C
authors.lastname: Lynde
authors.forename: Hong
authors.initials: H
authors.lastname: Liu
authors.forename: Jean
authors.initials: J
authors.lastname: Jacovella
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D012393:Rosacea / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D007559:Ivermectin