Long-term efficacy and safety of topical PRK 124 (0.125%) lotion (Pyratine-XR) in the treatment of mild-to-moderate rosacea.

Background: Many patients with rosacea cannot tolerate extended treatment periods with topical agents because their skin sensitivity is often increased.

Objective: To determine the long-term efficacy and tolerability of a new moisturizing lotion for improving the signs and symptoms of mild-to-moderate rosacea.

Methods: In a 48-week, open-label study, a moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK-124 (0.125%, Pyratine-XR, Senetek PLC, Napa, CA) was applied twice daily by 18 subjects with mild-to-moderate rosacea. Clinical improvements were assessed by the treating physician. Skin barrier function was measured by transepidermal water loss after treatment. Tolerability and cosmetic outcome were evaluated by subjects.

Results: Subjects experienced a mean 44 percent reduction in erythema severity and a mean 89 percent reduction in inflammatory lesion count at week 48. Reductions were significant (P < 0.05) in both erythema and lesions at weeks 24, 36 and 48. Statistically significant (P < or = 0.05) improvements in telangiectasias, transepidermal water loss and dryness were noted. Overall clinical improvement was observed in 81 percent of subjects and the investigator's global assessment steadily improved throughout the study. Treatments were well-tolerated and cosmetically acceptable. Treatment-induced skin irritation was not observed.

Conclusion: The new moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK 124 is efficacious, does not irritate skin, and is well tolerated for at least 48 weeks.