FDA approves Soolantra Cream for treatment of Rosacea- Galderma

Galderma Laboratories, L.P. has announced on 24 December 2014 the 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.