FDA Approves Ivermectin 1% Cream for Rosacea

January 2, 2015

Lead author and a Galderma consultant dermatologist Linda Stein Gold, M.D. writes to Dermatology Times that results from Soolantra (ivermectin) Cream, 1% were seen in clinical studies as early as week two, with continuous improvement in patients with inflammatory lesions of rosacea.

The FDA approved Soolantra (ivermectin) Cream 1% (Galderma) for the treatment of rosacea in December 2014. The once-daily topical has been shown in studies to be an effective, safe treatment for inflammatory lesions of papulopustular rosacea.

Researchers, who published study results March 2014 in the Journal of Drugs in Dermatology, conducted two randomized, double-blind, controlled studies of ivermectin 1% cream or vehicle once daily for 12 weeks on subjects with moderate to severe papulopustular rosacea. They assessed efficacy related to disease severity and inflammatory lesion counts; safety; and subject-reported quality of life.

READ MORE: Ivermectin effective for rosacea

In the two studies of nearly 1,400 subjects, the ivermectin 1% group achieved “clear or “almost clear” at rates of 38.4% and 40.1%, versus 11.6% and 18.8% for vehicle. Ivermectin also was superior to vehicle in reducing inflammatory lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups).

Lead author and a Galderma consultant dermatologist Linda Stein Gold, M.D. writes to Dermatology Times that results from Soolantra (ivermectin) Cream, 1% were seen in clinical studies as early as week two, with continuous improvement in patients with inflammatory lesions of rosacea. 

“Furthermore, in a separate head-to-head study with metronidazole 0.75% cream, Soolantra Cream was shown to be more efficacious from as early as week three onwards. While the mechanism of action of Soolantra Cream is unknown, ivermectin, the active ingredient in Soolantra Cream, has been reported to have both anti-inflammatory and antiparasitic activity,” Dr. Gold writes.

About 1% of subjects had skin burning sensation and skin irritation. Overall, however, the topical was well tolerated for up to 52 weeks, total, which Dr. Gold writes is critical for rosacea patients who often have sensitive skin.

Dr. Gold says that she might advise her rosacea patients to use Soolantra 1% Cream once daily for inflammatory lesions, along with a mild, non-irritating moisturizer with SPF. 

More on rosacea

Dr. Robert A. Weiss, of Maryland Laser Skin & Vein, discusses the cause, potential aggravators, and available treatments for rosacea with RealSelf at the 2013 ASDS meeting.

Intradermal neuromodulator injections show promise for treating rosacea - particularly in the form of erythematotela