Soolantra^®

(ivermectin CREAM, 1%)

Not an actual patient

Soolantra Cream combats inflammatory lesions of rosacea with a formulation designed for tolerability, utilizing Cetaphil^® Moisturizing Cream as the basis for the vehicle.¹

Proposed dual MOA of ivermectin^2-5,a

Anti-Inflammatory

Decreases cellular and humoral immune responses
Parent compound avermectin has been shown to significantly regulate TNF-α, IL-1β, and IL-10 in lipopolysaccharide-induced inflammation in in vitro studies

Antiparasitic

Vermicide
Demodex
- Published clinical case series

^aThe mechanism of action (MOA) of Soolantra® (ivermectin) Cream, 1% in treating rosacea lesions is unknown.

Interview with Dr. Linda Stein Gold,
Soolantra Cream Clinical Investigator

Soolantra Cream application instructions

Instruct patients to:

Apply Soolantra Cream to the affected areas of the face once a day. Use a pea-sized amount of Soolantra Cream for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer across the affected areas of the face, avoiding the eyes and lips.

Hands should be washed after applying Soolantra Cream
Cosmetics may be applied after Soolantra Cream has dried
Soolantra Cream is not for oral, ophthalmic, or intravaginal use

Important Safety Information

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Not for oral, ophthalmic or intravaginal use. Adverse Events: In clinical trials with SOOLANTRA® Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.

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.

*Rosacea: Beyond the visible report - Methods: Self-administered online survey covered 554 physicians and 710 patients from France, Germany, Italy, UK, Canada and the U.S. Participants were recruited using the Kantar online panel. In order to maximize the sample size no quote was set up. Therefore, the sample is not representative of the rosacea population of each country. Inclusion criteria for patients: Adults from 18 to 70 years of age, suffering with rosacea as diagnosed by a physician (Declarative), having taken a prescribed treatment in the past 12 months, and visited a physician at least twice in the past 12 months.
**The BURDEN survey is developed by Kantar Health as a self-administered online survey and supported by Galderma International. Participants were recruited using the Kantar online panel. In order to maximize the sample size no quota was set up. Therefore, the sample is not representative of the rosacea population in each country; consequently, the results of this study could be affected by selection bias and cannot be inferred to the whole rosacea population.
†www.rosacea.org

References: 1. Data on file. Galderma Laboratories, L.P. 2. Stankiewicz M, Cabaj W, Jonas WE, Moore LG, Millar K, Ng Chie W. Influence of avermectin on cellular and humoral immune responses of lambs. Vet lmmunol and lmmunopathol. 1995;44:347-358. 3. Labro MT. Anti-inflammatory activity of macrolides: a new therapeutic potential? J Antimicrob Chemother. 1998;4l(suppl B):37-46. 4. Ci X, Li H, Yu Q, et al. Avermectin exerts anti-inflammatory effect by downregulating the nuclear transcription factor kappa-B and mitogen-activated protein kinase activation pathway. Fundam Clin Pharmacol. 2009;23:449-455. 5. S. Del Rosso JQ, Gallo RL, Kircik L, Thiboutot D, Baldwin HE, Cohen D. Why is rosacea considered to be an inflammatory disorder? The primary role, clinical relevance, and therapeutic correlations of abnormal innate immune response in rosacea-prone skin. J Drugs Dermatol. 2012;11(6):694-700.

GALDERMA

Soolantra®

(ivermectin CREAM, 1%)

Proposed dual MOA of ivermectin2-5,a