Based on positive results demonstrated in previous studies of Pyratine-6 (0.1%), for the remediation of photodamaged skin and erythema which included unprecedented reduction in facial redness, in as early as two weeks, an additional study was initiated for acne rosacea. The follow up study was designed to extend these significant clinical findings by assessing the effects of Pyratine-6 (0.125%) in improving clinical signs and symptoms of acne rosacea.
Approximately 24 subjects with mild-to-moderate acne rosacea participated in the 12 week study. Subjects were evaluated at baseline, four, eight and 12 weeks. Evaluations included physician assessments of inflammatory lesion count, severity of erythema and telangiectasia, and overall clinical improvement. Patient assessments of signs and symptoms of rosacea and skin tolerance were also rated at each follow-up. In addition, transepidermal water loss measurements and facial photography were conducted at each visit.
Pyratine-6 produced a progressive decrease in the symptoms associated with rosacea including redness and acne lesions. All subject self-assessments showed good tolerability and cosmetic acceptability. After 12 weeks there was overall clinical improvement in 80% of subjects, including reduction of erythema and papules. Transepidermal water loss measurements showed a 22% decrease in water loss, which supports an improvement in skin barrier function. In view of the promising results, the current study has been extended to 48 weeks.