Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

Phase 3 Completed 480 enrolled MediGene

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

Timeline

Start: 2003-07
Primary completion: —
Completion: 2004-08

Outcome

Met primary endpoint

paper compared with 33.7% for vehicle (both P<.001). PMID 18515521 ↗

Publications

Tatti S, Swinehart JM, Thielert C, Tawfik H, Mescheder A, Beutner KR. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1371-9. doi: 10.1097/AOG.0b013e3181719b60.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sinecatechins	Unknown	10 %	Topical
Subject	Sinecatechins	Unknown	15 %	Topical