FDA Approves Soolantra Cream for Rosacea

Galderma Laboratories’ Soolantra (ivermectin) Cream, 1% has been approved by the FDA for the once-daily topical treatment of the inflammatory lesions, bumps, and pimples of rosacea, the company announced in a press release.

Rosacea is an inflammatory and vascular skin disorder affecting 16 million Americans, many of whom are women 30 years of age and older. Although the cause of rosacea is unknown, studies suggest that factors such as sun, alcohol, spicy food, and exercise can trigger the inflammation associated with the condition. Additional research has also indicated that rosacea may be connected with microscopic Demodex mites, which have been found to be more common on the faces of rosacea patients.

The approval was based on 2 phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies. Soolantra Cream met each of its primary efficacy endpoints in each study. During the trial, the treatment effects of Soolantra Cream were observed as early as week 2 with continuous improvement. Soolantra Cream was also found to be more effective than metronidazole 0.75% cream as early as week 3 during a head-to-head comparison.

“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,” said Linda Stein Gold, M.D., Galderma consultant and clinical investigator for the phase III studies of Soolantra Cream, in a press release. “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.”

Long-term extensions to the 12-week studies also found that Soolantra Cream was safe and well-tolerated for an additional 40 weeks (52 weeks total), a promising result for rosacea patients with sensitive skin. Some study participants reported skin burning sensation and skin irritation while using Soolantra Cream.