Green Tea Ointment Seems Effective for Genital Warts

WAIKOLOA, HAWAII — Sinecatechins ointment 15%—the first botanical approved by the Food and Drug Administration for prescription use—outperformed imiquimod cream 5% for treatment of external genital warts in a new cost-effectiveness analysis.

The analysis by Paul C. Langley, Ph.D., of the University of Minnesota, Minneapolis, used pharmacoeconomic modeling based on data from the two phase III, double-blind, vehicle-controlled, randomized trials of sinecatechins ointment 15% (Veregen) that included more than 1,000 patients, along with a systematic review of the published imiquimod (Aldara) literature, Dr. Brian Berman said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

As first-line therapy, the botanical was the winner with a sustained clearance rate of 51.9%, compared with 40.6% with imiquimod. Average treatment cost was lower, at $774 compared with $930. The cost per successful outcome was $1,492 with sinecatechins ointment and $2,289 with imiquimod (J. Med. Econ. 2010;13:1–7).

Factoring in the additional cost of second-line ablative therapy for patients who didn't respond to the initial topical regimen, the average cost of treatment climbed to $943 in the sinecatechins arm and $1,138 in the imiquimod group.

“Take this cost-effectiveness analysis with a grain of salt. I find cost-effectiveness analyses are usually paid for by the product that does well, as was the case here,” observed Dr. Berman, professor of dermatology at the University of Miami.

Sinecatechins ointment 15% is a green tea extract, the chief antioxidant component of which is epigallocatechin gallate. The botanical is approved as prescription therapy for both external genital and perianal warts.

Sinecatechins ointment was significantly more effective in women than in men. Clearance of all warts by week 16 occurred in 60.4% of women and 47.3% of men.

The recurrence rate was remarkably low: just 6.8% during 12 weeks of follow-up after completing the 16 weeks on sinecatechins. “Most studies of other agents have 20%–50% recurrence rates,” the dermatologist noted.

Also noteworthy was the fact that the recurrence rate in the control group was even lower, at 5.9%. “It turns out there's an irritant in the vehicle. Whether that has something to do with the low recurrence rate is not clear,” Dr. Berman said.

Disclosures: Dr. Berman disclosed financial relationships with Graceway Pharmaceuticals (Aldara) and PharmaDerm (Veregen). SDEF and this news organization are owned by Elsevier.