FDA Approves Topical Treatment for Rosacea

Galderma Laboratories LP today announced the US Food and Drug Administration (FDA) has approved Soolantra (ivermectin) Cream, 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea.

In clinical trials, Soolantra showed results in as little as 2 weeks of treatment. When compared head-to-head with metronidazole 0.75% cream Soolantra showed better results as early as the third week of treatment. Ivermectin (the active ingredient in Soolantra Cream) has been shown to have both anti-inflammatory and anti-parasitic activity.

“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,” noted Linda Stein Gold, MD, who served as a consultant and investigator during phase 3 trials of Soolantra. “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.”

The FDA approved Soolantra Cream based on results from 2 phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies in which Soolantra Cream met each of its co-primary efficacy endpoints. During long-term extensions to the 12-week studies, Soolantra Cream was also safe and well-tolerated for an additional 40 weeks (up to 52 weeks in total).

During the trials the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation.

Rosacea is a skin disorder that affects 16 million Americans, predominantly women, age 30 and older. According to the news release from Galderma, “there are multiple triggers for the inflammation associated with the condition, including sun, alcohol, spicy food and exercise. Recent studies have further solidified that generally harmless microscopic Demodex mites may also be a culprit. These mites are normal inhabitants of everyone’s skin, but may appear in greater numbers on the faces of people with rosacea.”

In one study of patients with rosacea, 46 percent of participants reported that they changed their medication, usually due to lack of improvement, demonstrating the “ongoing need for patients and healthcare practitioners to have other effective treatment options for the condition.”

Rosacea can “cause embarrassment, anxiety and frustration, and can have a negative impact on the patient's social life. Stinging, burning and sensitivity of the skin are common, and in some cases, the eyes can become red, dry and itchy. Triggers for the condition may include spicy foods, alcohol, emotional stress, sun exposure, hot baths and generally harmless, microscopic Demodex mites found on the skin.”