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Based on positive results demonstrated in previous studies ofPyratine-6(TM) (0.1%), for the remediation of photodamaged skin and erythemawhich included unprecedented reduction in facial redness, in as early as twoweeks, an additional study was initiated for acne rosacea. The follow upstudy was designed to extend these significant clinical findings by assessingthe effects of Pyratine-6(TM) (0.125%) in improving clinical signs andsymptoms of acne rosacea. Twenty-four subjects with mild-to-moderate acnerosacea participated in the 12 week study. Subjects were evaluated atbaseline, 4, 8 and 12 weeks. Evaluations included physician assessments ofinflammatory lesion count, severity of erythema and telangiectasia, andoverall clinical improvement. Patient assessments of signs and symptoms ofrosacea and skin tolerance were also rated at each follow-up. In addition,transepidermal water loss measurements and facial photography were conductedat each visit.
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Pyratine-6(TM) produced a progressive decrease in the symptoms associatedwith rosacea including redness and acne lesions. All subject self-assessmentsshowed good tolerability and cosmetic acceptability. After 12 weeks there wasoverall clinical improvement in 80% of subjects, including reduction oferythema and papules. Transepidermal water loss measurements showed a 22%decrease in water loss, which supports an improvement in skin barrierfunction. In view of the promising results, the current study has beenextended to 48 weeks.
Rosacea is a common chronic facial dermatosis, affecting 14 millionAmericans, that is characterized by persistent erythema, telangiectasia,papules and pustules. Patients with rosacea are often unable to tolerateextended treatment periods with topical agents as a result of skin sensitivitythat accompanies rosacea. Due to the chronic nature of rosacea, there is acontinuing need for efficacious treatments that provide sustained relief ofits principal signs and symptoms.
Dr. Arisa Ortiz from the University of California Irvine, who ispresenting the results of this study at the 2008 International InvestigativeDermatology meeting in Kyoto, Japan, stated, "All study subjects reported goodtolerability and cosmetic acceptability to Pyratine-6 (TM). The majority ofsubjects showed reductions in erythema, papules, burning, stinging, anddryness, all of which are signs and symptoms associated with acne rosacea.Transepidermal water loss measurements showed a decrease in water loss whichsupports an improvement in skin barrier function, attesting to themoisturizing properties of this compound."
Commenting on these findings, Frank Massino, Senetek Chairman and ChiefExecutive Officer stated, "We are pleased by the positive study findings asthis further confirms the excellent safety and effectiveness profile ofPyratine-6(TM). Response to Pyratine-6(TM) in the U.S. physician market hasbeen outstanding and we look forward to expanding our sales and marketingefforts to accommodate increasing demand for this important product."
About Senetek PLC
Senetek PLC (OTCBB: SNKTY) is a Life Sciences company engaged in thedevelopment of breakthrough technologies that target the science of healthyaging. The Company's extensive research collaborations have resulted in astrong pipeline of patented compounds and products with broad therapeuticapplications and a leading presence in dermatology. Senetek collaborates withestablished specialty pharmaceutic
