Ivermectin Cream, 1% (Soolantra , Galderma Laboratories, L.P.) received FDA approved for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea.
In clinical studies, ivermectin Cream, 1% effects were seen as early as week 2 with continuous improvement in patients with inflammatory lesions of rosacea. In a separate head-to-head study with metronidazole 0.75% cream – a current gold standard – ivermectin Cream, 1% was shown to be more efficacious from as early as week 3 onwards. While the mechanism of action of ivermectin Cream, 1% is unknown, the active ingredient ivermectin has been reported to have both anti-inflammatory and antiparasitic 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,” says Linda Stein Gold, M.D., Galderma consultant and clinical investigator for the phase 3 studies of the cream. “While some rosacea treatments for the common bumps and pimples of the condition may take more than four weeks to show effect, Soolantra Cream may provide initial results as early as week 2.”
The approval of ivermectin Cream, 1% was based on two pivotal phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies where Soolantra Cream met each of its co-primary efficacy endpoints. The onset of treatment effect was observed as early as week two with continuous improvement. In 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). Some study subjects experienced skin burning sensation and skin irritation while using the cream.
