The Food and Drug Administration has approved a topical formulation of ivermectin for the once-daily topical treatment of inflammatory lesions related to rosacea. The drug will be marketed as Soolantra by Galderma Laboratories.

Ivermectin 1% cream was found to be safe and effective for patients in with moderate to severe papulopustular rosacea in two identical phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies led by Dr. Linda Stein Gold, director of dermatology clinical research and a division head of dermatology at the Henry Ford Hospital in Detroit.

In both studies, a total of 910 patients were randomized 2:1 to receive ivermectin 1% cream or a control cream once daily. The two coprimary endpoints were the percentage of patients who achieved a “clear” or “almost clear” score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.

The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76%-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.

At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success, compared with those in the control group (38%-40% vs. 12%-19%, respectively; P less than .001). That difference was seen as early as week 4. Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively)

In a separate head-to-head study comparing ivermectin 1% cream with metronidazole 0.75% topical cream, investigators also found that the former was more effective at treating rosacea.

“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” Dr. Stein Gold said in a statement . “While some rosacea treatments for the common bumps and pimples of the condition may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.”

Dr. Stein Gold is a consultant for Galderma.

Doug Brunk contributed to this report.