Long-Term Safety of Ivermectin 1% Cream vs Azelaic Acid 15% Gel in Treating Inflammatory Lesions of Rosacea
Linda Stein Gold, MD; Leon Kircik, MD; Joseph Fowler, MD; J. Mark Jackson, MD; Jerry Tan, MD; Zoe Draelos, MD; Alan Fleischer, MD; Melanie Appell, MD; Martin Steinhoff, MD; Charles Lynde, MD; Jeffrey Sugarman, MD, PhD; Jean Jacovella, MD
Papulopustular rosacea (PPR) is a chronic, inflammatory facial skin disease characterized by inflammatory lesions. There is no cure for rosacea and managing the disease frequently requires long-term treatment. Ivermectin (IVM) 1% cream contains ivermectin, a semi-synthetic derivative that belongs to the avermectin family of macrocyclic lactones and has demonstrated anti-inflammatory and anti-parasitic activity in vitro and in vivo. IVM 1% cream has been shown to be safe and efficacious in two 12-week phase 3 trials. Two 40-week extension studies of those phase 3 trials assessed the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects initially treated with IVM 1% cream QD continued and those initially treated with vehicle gel QD were switched to AzA 15% gel BID. The incidence of adverse events (AEs) was similar between the 2 treatment groups in both studies. However, there was a lower incidence of related AEs with IVM 1% cream vs AzA 15% gel and no subjects in the IVM 1% cream group discontinued due to a related AE. The observed efficacy with IVM 1% cream continued to increase throughout the trial as the percentage of subjects with an investigator global assessment (IGA) score of clear or almost clear was higher at the end of the study than baseline. The results of these 2 studies, in conjunction with the phase 3 studies, support the use of IVM 1% cream for the long-term management of PPR as a safe and efficacious treatment.