An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA Cream, 1% once daily with METROCREAM Topical 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).1,2,4
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.1,2,4
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