Condylomata AcuminataPhase 3NCT00449982
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
A Phase 3 study testing Polyphenon E Ointment 10%, Polyphenon E Ointment 15% in people with Condylomata Acuminata, run by MediGene at 12 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Condylomata Acuminata
- What is being tested?
- Polyphenon E Ointment 10%, Polyphenon E Ointment 15%
- How many people
- 480 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Jul 2003to Aug 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
United States6 sites
Study site
Burlington, Vermont
Study site
Davis, San Diego, California
Study site
Denver, Colorado
Study site
Houston, Dallas, Austin, Texas
Study site
New York, New York
Study site
Portland, Oregon
Mexico1 site
Study site
Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla
About this study
Official title: 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
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.
Read the detailed description
External genital warts are non-malignant tumors caused by infections of the human papillomavirus (HPV), mainly types 6 and 11. Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves.
Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo
- Conditions
- Condylomata Acuminata
- Being tested
- Polyphenon E Ointment 10%, Polyphenon E Ointment 15%
- Keywords
- Genital warts, Condylomata acuminata, Human Papillomavirus, Polyphenon E, Green tea extract, Vulva, Penis, Anus
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon E Ointment 10%, Polyphenon E Ointment 15%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Related adverse events during the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startJul 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Condylomata AcuminataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karl R. Beutner, M.D., Ph.D., Principal investigator, Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449982
- Sponsor's protocol ID
- CT 1018
- Status last verified
- Mar 2007
- First submitted
- 20 Mar 2007
- Last updated
- 21 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18515521
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00449982
- Acronym / sponsor ID
- CT 1018
- Conditions
- Condylomata Acuminata
- Keywords
- Genital warts, Condylomata acuminata, Human Papillomavirus, Polyphenon E, Green tea extract, Vulva, Penis, Anus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Aug 2004
- First posted
- 21 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
External genital warts are non-malignant tumors caused by infections of the human papillomavirus (HPV), mainly types 6 and 11. Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves.
Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenon E Ointment 10%, Polyphenon E Ointment 15% | Drug | – |
Primary outcome
Complete clearance of all warts within a maximum of 16 weeks treatment
Severe local reaction during the treatment period
6 secondary outcomes
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
Related adverse events during the treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2007.
- Derived from this study: PubMed 18515521Tatti 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.
Related trials for Condylomata Acuminata
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
Active, not recruitingPhase 3
Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Cervical Intraepithelial Neoplasia, Cervical Cancer
Active, not recruitingPhase 3
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl R. Beutner, M.D., Ph.D. principal investigator
Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyphenon E Ointment 10%, Polyphenon E Ointment 15% in people with Condylomata Acuminata, run by MediGene at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Argentina, Chile, Colombia, Mexico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clearance of all warts within a maximum of 16 weeks treatment. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2007.