Novel Treatment Soolantra® (ivermectin) Cream, 1%, Now Approved
The following announcement was issued by Galderma Laboratories, L.P.:
Novel Treatment Soolantra® (ivermectin) Cream, 1%, Now Approved to Help Reduce the Skin Inflammation of Rosacea
If you are currently suffering from rosacea-related inflammation, you are not alone. There are an estimated 16 million people in the U.S. with rosacea, and many report that the condition causes embarrassment and anxiety while negatively impacting their social lives.
Now there is a novel, FDA-approved treatment option, Soolantra® (ivermectin) Cream, 1%, available to rosacea patients. This once-daily, antibiotic-free topical prescription is approved for the treatment of inflammatory lesions, or bumps and pimples, of rosacea.
Although the cause of rosacea is unknown, research suggests that there are multiple triggers for the inflammation associated with the condition, such as sun, alcohol, spicy food and exercise. Recent studies have further shown that microscopic, generally harmless 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.
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. In clinical studies, the effects of Soolantra Cream were seen as early as week two with continuous improvement in patients with inflammatory lesions of rosacea. You may experience skin burning sensation and skin irritation while using Soolantra Cream.
To find out whether Soolantra Cream might be right for you, speak with your dermatologist. You can also learn more at www.Soolantra.com.
Soolantra® is a trademark of Galderma S.A.
Important Safety Information - Soolantra® Cream
Indication: SOOLANTRA® (ivermectin) Cream, 1%, is indicated for the treatment of inflammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream, the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation. Warnings / Precautions: Not for oral, ophthalmic or intravaginal use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit WWW.FDA.GOV/MEDWATCH or call 1-800-FDA-1088.
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The National Rosacea Society is a 501(c)(3) nonprofit organization whose mission is to improve the lives of people with rosacea by raising awareness, providing public health information and supporting medical research on this widespread but little-known disorder. The information the Society provides should not be considered medical advice, nor is it intended to replace
consultation with a qualified physician. The Society does not evaluate, endorse or recommend any particular medications, products, equipment or treatments. Rosacea may vary substantially from one patient to another, and treatment must be tailored by a physician for each individual case. For more information, visit About Us.