60% MORE subjects were rated clear§ vs MetroCream® (metronidazole) Topical Cream (P<0.001)1-3
NEARLY 1 OUT OF 3 SUBJECTS REMAINED CLEAR§ or almost clear at 1 year4
CETAPHIL® MOISTURIZING CREAM was the basis for the vehicle3
§CLEAR is defined as IGA score of 0 according to the IGA (Investigator Global Assessment) scale, which is commonly used by dermatologists.
aA phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA Cream, 1% once daily with metronidazole 0.75% cream twice daily in 962 subjects 18 years of age 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 the relapse after a treatment-free period (Part B).3,4
In Part B, subjects were followed every 4 weeks for up to 36 additional weeks (Weeks 16-52). If relapse (defined as IGA score of ≥2 [mild, moderate, or severe]) occurred, subjects were re-treated with the same treatment they had received during the initial 16-week study (Part A). Re-treatment was stopped after the exact number of days it took for IGA to return to an IGA score of ≤1 (clear or almost clear), with a maximum duration of re-treatment of 16 consecutive weeks to mimic the Part A treatment duration. Several re-treatment periods were permitted.3,4
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.
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