Senetek PLC announced positive study results from a clinical trial of Pyratine-6 in patients with acne rosacea. The findings have been accepted for presentation at the International Investigative Congress of Dermatology at its May 2008 meeting in Kyoto, Japan.
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. Twenty-four subjects with mild-to-moderate acne rosacea participated in the 12 week study. Subjects were evaluated at baseline, 4, 8 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.
Rosacea is a common chronic facial dermatosis, affecting 14 million Americans, that is characterized by persistent erythema, telangiectasia, papules and pustules. Patients with rosacea are often unable to tolerate extended treatment periods with topical agents as a result of skin sensitivity that accompanies rosacea. Due to the chronic nature of rosacea, there is a continuing need for efficacious treatments that provide sustained relief of its principal signs and symptoms.
Dr. Arisa Ortiz from the University of California Irvine, who is presenting the results of this study at the 2008 International Investigative Dermatology meeting in Kyoto, Japan, stated, "All study subjects reported good tolerability and cosmetic acceptability to Pyratine-6 . The majority of subjects showed reductions in erythema, papules, burning, stinging, and dryness, all of which are signs and symptoms associated with acne rosacea. Transepidermal water loss measurements showed a decrease in water loss which supports an improvement in skin barrier function, attesting to the moisturizing properties of this compound."
Commenting on these findings, Frank Massino, Senetek Chairman and Chief Executive Officer stated, "We are pleased by the positive study findings as this further confirms the excellent safety and effectiveness profile of Pyratine-6. Response to Pyratine-6 in the U.S. physician market has been outstanding and we look forward to expanding our sales and marketing efforts to accommodate increasing demand for this important product."