Innovation in Papulopustular Rosacea Treatment: Efficacy and Safety of Ivermectin 1% Cream
Linda Stein Gold, MD; Leon Kircik, MD; Joseph Fowler, MD; Jerry Tan, MD; Zoe Draelos, MD; Alan Fleischer, MD; Melanie Appell, MD; Martin Steinhoff, MD; Charles Lynde, MD; Jean Jacovella, MD
Introduction & Objectives: Papulopustular rosacea (PPR) is an inflammatory, chronic facial skin disease characterized by persistent erythema and papules and pustules. Its exact cause remains unknown, but dysregulation of the innate immune system is believed to play a role. An increased density of Demodex folliculorum in patients with PPR may also be a contributing factor. Ivermectin is an avermectin-class drug used to treat parasites. Immunopharmacological studies have shown this class of drugs to have anti-inflammatory properties through inhibition of inflammatory cytokines and induction of anti-inflammatory cytokines. Subjects & Methods: Two phase 3 clinical studies investigated the efficacy and safety of once-daily ivermectin 1% cream (IVM) in subjects with moderate to severe PPR. These were multicenter, randomized, double-blind, parallel-group, vehicle-controlled studies of identical design lasting 12 weeks for the first part of a 3 part study. Men and women at least 18 years old with an investigator global assessment (IGA) score of moderate or severe and 15 to 70 inflammatory lesions were enrolled and randomized 2:1 to IVM or vehicle cream. Results: A significantly higher percent of subjects in each study achieved treatment success at week 12 (IGA of clear or almost clear) with IVM than vehicle cream (both P < .001). Week 12 reductions in inflammatory lesions were also significantly better with IVM over vehicle cream (both P < .001). IVM was well tolerated; 3.4% of subjects reported a related adverse event compared to 7.2% for vehicle cream. Summary: The results of these studies indicate that IVM is an effective and safe treatment for inflammatory lesions of PPR.