Rosacea treatment and triggers info is on the way.
In pivotal trials, once-daily Soolantra® (ivermectin) Cream, 1% was proven safe and well tolerated with a similar number of treatment-related adverse events as vehicle cream.1
In controlled clinical trials with Soolantra Cream the most common adverse reactions (incidence ≤1 %) included skin burning sensation and skin irritation.1
Overall Safety Profile Comparable to Vehicle1
TREATMENT-RELATED ADVERSE EVENTS (AEs) OCCURRING IN ≥1% OF SUBJECTS1
|SOOLANTRA CREAM QD (n=910)||VEHICLE QD (n=461)|
|TOTAL NUMBER OF RELATED AEs, n||41||45|
|TOTAL NUMBER OF SUBJECTS WITH RELATED AEs, n (%)*||31 (3.4)||33 (7.2)|
|SKIN-BURNING SENSATION||9 (1.0)||10 (2.2)|
|SKIN IRRITATION||6 (0.7)||9 (2.0)|
|PRURITUS||5 (0.5)||4 (0.9)|
|PAIN OF SKIN||1 (0.1)||6 (1.3)|
*A subject was counted once even if the subject experienced more than 1 adverse event during the study.
SPECIFICALLY FORMULATED FOR PATIENTS WITH INFLAMMATORY LESIONS OF ROSACEA
CETAPHIL® MOISTURIZING CREAM WAS THE BASIS FOR THE VEHICLE1
Two phase 3, multicenter, randomized, double-blind, 12-week, vehicle- controlled, parallel-group studies assessing the efficacy and safety of Soolantra Cream once daily in 1371 subjects with moderate to severe papulopustular rosacea (investigator global assessment score of 3 or 4).2
- Data on file. Galderma Laboratories, L.P.
- Stein Gold L, Kircik L, Fowler J, et al; Ivermectin Phase III Study Group. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316-323.
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 entire 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.