Efficacy

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.

† Treatment success defined as ‘almost clear’ (IGA 1) or ‘clear’ (IGA 0)
*A Phase 3, investigator-blind, multicenter, randomized, parallel-group study comparing the efficacy and safety of ivermectin, 1% cream, once daily with metronidazole 0.75% cream, twice daily in 962 subjects aged 18 years and older with ‘moderate’ to ‘severe’ papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period (Part A). A total of 757 successfully treated subjects, rated ‘clear’ or ‘almost clear’ (IGA score of 0 or 1), continued to the 36-week extension evaluating relapse after a treatment-free period (Part B)^1,2
IGA=Investigator’s Global Assessment.

References: 1. Taieb A, et al. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. 2015;172:1103–1110. 2. Taieb A, et al. Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs. metronidazole 0.75% cream: 36-week extension of the ATTRACT randomized study. J Eur Acad Dermatol Venereol. 2015;829–836. 3. Del Rosso JQ, et al. J Am Acad Dermatol. 2007;56:791-802.