Abstract Number: 26

Ivermectin 1% Cream, an effective and safe topical treatment of inflammatory lesions of papulopustular rosacea

P. Foley, L. Stein-Gold, L. Kircik, J. Fowler, M. Jackson, J. Tan, Z. Draleos, A. Fleischer, M. Appell, M. Steinhoff, C. Lynde, L. Hong, J. Jacovella

Meeting: 2016 Dermcoll

Session Information

Date: -

Session Title: Clinical Updates

Session Time: -

Background: Treatments for papulopustular rosacea (PPR) are limited. The objective was to demonstrate the efficacy and safety of once-daily application of ivermectin 1% cream in subjects with moderate to severe PPR.

Methods: Two identical 12-week, randomized, double-blind, parallel group, vehicle controlled studies were conducted with ivermectin 1% cream (IVM 1%) in subjects with moder- ate to severe PPR. Main efficacy assessments were Investiga- tor’s Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance param- eters. Subjects evaluated their rosacea and completed satis- faction 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 < 0.001), respectively. IVM 1% was superior to vehicle in terms of reduction from baseline in inflamma- tory lesion counts (76.0% and 75.0% vs. 50.0% for both vehi- cle groups, respectively). For all endpoints, starting at week 4 and continuing through the end of the study (week 12), IVM 1% was statistically significantly superior (p < 0.001). 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 “excel- lent” or “good” improvement, along with an improved QoL. Conclusions: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.