title: Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials.
abstract: Papulopustular rosacea (PPR) is characterized by facial erythema and inflammatory lesions believed to be primarily caused by dysregulation of the innate immune system. More recent evidence also suggests that Demodex folliculorum mites may contribute to the etiology of PPR. Ivermectin (IVM) 1% cream is a novel topical treatment developed to treat PPR. Two phase 3 trials have demonstrated that IVM 1% cream was significantly better than vehicle at investigator global assessment (IGA) success rate and lesion reductions and that it was safe and well tolerated. Two 40-week extension studies of those trials were conducted to assess the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects originally treated with IVM 1% continued on IVM 1% and those originally treated with vehicle switched to AzA 15% gel. IVM 1% cream was safe throughout the study with a lower incidence of related adverse events (AEs) compared to AzA 15% gel. No subjects in the IVM 1% cream group discontinued either study due to a related AE. IVM 1% also continued to be efficacious during the 40-week extension studies as the percentage of subjects with IGA scores of clear or almost clear was higher at the end of the study compared to baseline. The results of these 40-week extension studies support the use of IVM 1% cream as a long-term therapy for PPR as IVM 1% cream was shown to be safe and effective for up to 52 weeks of total treatment.
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
authors.forename: Leon
authors.initials: L
authors.lastname: Kircik
authors.forename: Joseph
authors.initials: J
authors.lastname: Fowler
authors.forename: J Mark
authors.initials: JM
authors.lastname: Jackson
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: Jeffrey
authors.initials: J
authors.lastname: Sugarman
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*; D003998:Dicarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012393:Rosacea / Q000188:drug therapy* / Q000473:pathology; D016037:Single-Blind Method; D063465:Skin Cream; D013997:Time Factors; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D005782:Gels; D007559:Ivermectin; C010038:azelaic acid