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
1 other identifier
interventional
480
7 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2003
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 20, 2007
CompletedFirst Posted
Study publicly available on registry
March 21, 2007
CompletedMarch 21, 2007
March 1, 2007
March 20, 2007
March 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete clearance of all warts within a maximum of 16 weeks treatment
Severe local reaction during the treatment period
Secondary Outcomes (6)
Time to complete clearance of all warts, of all baseline warts, and of all new warts
Partial clearance of warts at the end of treatment
Recurrence of any wart during the follow-up period
New warts during treatment and the follow-up period
Local sings and symptoms at the wart sites
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MediGenelead
Study Sites (12)
Unknown Facility
Davis, San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Houston, Dallas, Austin, Texas, United States
Unknown Facility
Burlington, Vermont, United States
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Santiago, Temuco, Chile
Unknown Facility
Colombia, Bogota, Medellin, Risaralda, Colombia
Unknown Facility
Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla, Mexico
Unknown Facility
Lima, Calao, Peru
Unknown Facility
Bucaresti, Brasov, Iasi, Cluj-Napoca, Romania
Related Publications (1)
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.
PMID: 18515521DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl R. Beutner, M.D., Ph.D.
Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2007
First Posted
March 21, 2007
Study Start
July 1, 2003
Study Completion
August 1, 2004
Last Updated
March 21, 2007
Record last verified: 2007-03