Clinical trial · Interventional
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
A Randomized, Double-Blind, Three-Arm Parallel-Group, Placebo-Controlled Phase 3 Trial to Investigate the Clinical Efficacy and Safety of Polyphenon E in the Treatment of External Genital Warts
NCT00449982CI-TRIAL-00000644completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Condylomata Acuminata | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polyphenon E Ointment 10%, Polyphenon E Ointment 15% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Complete clearance of all warts within a maximum of 16 weeks treatment
- measure
- Severe local reaction during the treatment period
Secondary outcomes (6)
- measure
- Time to complete clearance of all warts, of all baseline warts, and of all new warts
- measure
- Partial clearance of warts at the end of treatment
- measure
- Recurrence of any wart during the follow-up period
- measure
- New warts during treatment and the follow-up period
- measure
- Local sings and symptoms at the wart sites
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years at the time of enrollment * Clinical diagnosis of external genital warts (located genital, inguinal, perineal or perianal) * At least 2, but no more than 30 external genital warts * A total wart area between 12 and 600mm² * Negative pregnancy test and willingness to use effective contraception (for women of child-bearing potential) * For partners of male patients who are of child-bearing potential: use of effective contraception during the treatment period * Written informed consent * Ability to comply with the requirements of the study Exclusion Criteria: * Participation in an investigational trail within 30 days prior to enrollment * Previous participation in a trial investigating Polyphenon E in the treatment of external genital warts * Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration * Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration * Systemic intake of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment and for the whole study duration * Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 month * Any current and/or recurrent pathologically relevant genital infections other than genital warts * Current known acute or chronic infection with HBV or HCV * Known HIV infection * Any current uncontrolled infection * Organ allograft * For female patients: pregnancy or lactation * Known allergies against any of the ingredients of the treatments * Any chronic or acute skin condition susceptible of interfering with the evaluation of the drug effect * Any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study * Internal (vaginal or rectal) warts requiring treatment
References
Publications (1)
- DERIVEDTatti 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. PMID 18515521