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.


Objective: To estimate the clinical efficacy of topical sinecatechins, a defined green tea extract, in the treatment of external genital and perianal warts.

Methods: This was a randomized, double-blind, vehicle-controlled trial involving 502 male and female patients aged 18 years and older, with 2-30 anogenital warts ranging from 12 to 600 mm(2) total wart area. Patients applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily for a maximum of 16 weeks or until complete clearance of all warts, followed by a 12-week treatment-free follow-up to assess recurrence.

Results: Complete clearance of all baseline and newly occurring warts was obtained in 57.2% and 56.3% of patients treated with sinecatechins ointment 15% and 10%, respectively, compared with 33.7% for vehicle (both P<.001). Significance was observed at weeks 4 and 6 and all subsequent visits. Numbers needed to treat were 4.3 and 4.4. Partial clearance rates of at least 50% were reported for 78.4% and 74.0% of patients in the sinecatechins ointment 15% and 10% groups compared with 51.5% of vehicle patients. During follow-up, recurrence of any wart was observed in 6.5%, 8.3%, and 8.8% in the sinecatechins ointment 15% group, sinecatechins ointment 10% group, and vehicle patients, respectively. A total of 3.7%, 8.3%, and 0.0% developed new warts, respectively. A total of 87.7% and 87.3% of patients in the sinecatechins ointment 15% and 10% groups, and 72.1% of vehicle patients experienced application site reactions; 49.2%, 46.2%, and 65.4% of those, respectively, were mild or moderate.

Conclusion: Topical sinecatechins ointments 15% and 10% are effective and well-tolerated in the treatment of anogenital warts.

Clinical trial registration:,, NCT00449982.

Level of evidence: I.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anus Diseases / drug therapy*
  • Catechin / administration & dosage
  • Catechin / therapeutic use*
  • Condylomata Acuminata / drug therapy*
  • Double-Blind Method
  • Female
  • Genital Diseases, Female / drug therapy*
  • Genital Diseases, Male / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Ointments
  • Plant Extracts / administration & dosage
  • Plant Extracts / therapeutic use
  • Recurrence
  • Tea*
  • Treatment Outcome


  • Ointments
  • Plant Extracts
  • Tea
  • Catechin

Associated data