Sep 1, 2009

- Green tea extract (polyphenone) Phase 2, shows promise

Phase II management of papulopustular rosacea with 2% green tea extract (-EGCg) in a hydrophilic cream: A placebo-controlled, double-blind study, Tanweer Syed, MD, PhD, San Francisco, CA, United States; Seyed Ahmad, University of California, Berkeley, CA, United States; Amit Bhakhri, University of California, San Francisco, CA, United States

Objective: We sought to evaluate the clinical efficacy, tolerability, safety, and beneficial effects of 2% polyphenone (-EGCg, epigallocatechin gallate) incorporated in a hydrophilic cream to treat and manage papulopustular rosacea.

Methods: Preselected subjects (N = 100; 37 men/63 women) aged 25 to 50 years having visible signs of papules/pustules were sequentially randomized into two parallel groups. An identical precoded tube containing 50 g (either active drug or placebo) was allocated to each subject with instructions on how to topically apply the trial cream 2 times a day for 4 weeks. Cure was defined as absence of complete clinical signs of treated inflammation. Photographic and optical techniques were used both at baseline and on a weekly basis.

Results: By the end of the study, marked beneficial improvement was observed in both groups. Breaking the code revealed that 2% polyphenone in a hydrophilic cream yielded statistically significantly higher reduction in mean inflammatory lesion count than placebo. The most frequently assessed signs of rosacea were papules/pustules (38), erythema (34), and telangiectasia (28). Using the Investigator’s Global Assessment, therapeutic success in terms of a clear, minimal, or mild result was documented in 72% of patients treated with 2% polyphenone (-EGCg) cream (P <.0001).

Conclusion: The study substantiates that 2% polyphenone (-EGCg) in a hydrophilic cream is safe, tolerable, and significantly more beneficial in contributing superior clinical efficacy than placebo in the treatment and management of papulopustular rosacea.


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