Galderma Laboratories announced that the U.S. Food and Drug Administration (FDA) approved Soolantra® (ivermectin) Cream, 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. Rosacea is a common, but often misunderstood, skin disorder affecting 16 million Americans, predominantly women, ages 30 and older. Although the cause of rosacea is unknown, research suggests that 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 clinical studies, Soolantra Cream effects were seen 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 – a current gold standard – 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.

“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 3 studies of Soolantra 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 two.”