The treatment of rosacea: the safety and efficacy of sodium sulfacetamide 10% and sulfur 5% lotion (Novacet) is demonstrated in a double-blind study

Rosacea is a chronic skin disease of adults characterized by facial flushing, erythema, telangiectasia, and inflammatory papules and pustules. The open-label use of the combination of topical sodium sufacetamide (10%) and sulfur (5%) has been reported to be helpful in controlling the disorder but observations from well-controlled trials are lacking. This vehicle-controlled double-blind study was performed to determine the safety and efficacy of a novel formulation of this combination in treating rosacea. A total of 103 patients with moderate to severe facial erythema and at least five papules and/or pustules bilaterally were enrolled, and 94 completed the study. Treatment was randomly assigned. Active or vehicle lotion was applied twice daily for the duration of the 8-week trial. Efficacy was evaluated by counting inflammatory lesions, assessing the severity of facial erythema, and by both a physician's and a subject's global evaluation. A product satisfaction questionnaire was also completed by all patients. By week 4 there was significant improvement in all efficacy parameters favoring treatment with active lotion over vehicle lotion and maximum benefit was seen at week 8. Inflammatory lesions had decreased by 65 ± 5.3% (mean ± SEM) in the active treatment group compared with 44 ± 5.0% in the vehicle treatment group by week 4 (P=0.002), and by 78 ± 4.5% vs 36 ± 8.9%, respectively, by week 8 (P<0.001). Facial erythema had decreased by week 4 in 66% of the patients in the active treatment group compared with 33% in the vehicle group (P=0.005) and by week 8 83% vs 31% of each group, respectively, had improved (P<0.001). The most common adverse experiences were application site reactions which decreased in frequency over time. This formulation of topical sodium sulfacetamide (10%) and sulfur (5%) lotion was effective in reducing the inflammatory lesions and erythema of rosacea and was well tolerated and accepted by the patients.