Genital WartsPhase 4NCT01082302
Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage
A Phase 4 study testing Polyphenon E (Veregen) 15% ointment and Green Tea Beverage with defined catechin content in people with Genital Warts and Perianal Warts, run by MediGene at 1 site in Germany.
Trial summary
This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genital Warts, Perianal Warts
- What is being tested?
- Polyphenon E (Veregen) 15% ointment and Green Tea Beverage with defined catechin content
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Aug 2010
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For both subject groups (treatment arms 1 + 2):
- Male and female subjects, 18 years of age or older at the time of enrollment. Subjects will be stratified by gender.
- Written informed consent.
- Ability to comply with the requirements of the study.
- For patients (treatment arm 1, additionally):
- Clinical diagnosis of external genital and perianal warts which can be located: in men: over the glans penis, foreskin, penis shaft, and scrotum; in women: on the vulva; in both gender: in the inguinal, perineal, and perianal areas.
- A total wart area of at least 100 mm² and a maximum of 2500 mm².
- For women of child-bearing potential: negative pregnancy test and willingness to use two effective methods of contraception throughout their study participation is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection). For male patients and partners of male patients who are of childbearing potential: use of two methods of effective contraception during the treatment period is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection).
Who cannot join
- For both subject groups (treatment arms 1 + 2):
- Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration.
- Any current uncontrolled infection.
- Current known acute or chronic infection with Hepatitis virus B or C.
- Known Human immunodeficiency virus infection.
- Subjects with known history of chronic (diabetes, hypertension, gastritis, etc.) or consuming diseases (cancer, multiple sclerosis, etc.), chronic inflammation, or liver or renal insufficiency.
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- Any chronic or acute condition including the skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect.
- Laboratory data above the upper normal range.
- Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration, with the exception of acyclovir and the related drugs famciclovir and valaciclovir.
- Systemic intake of immunosuppressive or immuno-modulatory medication or vaccination within 30 days prior to enrollment and for the whole study duration.
- Organ allograft recipient.
- Medication intake, including over the counter products and dietary supplements such as iodine, fluoride, or vitamins, which would interfere with study results, except paracetamol and oral contraceptives, within one week before and during the study course. Subjects are not allowed to consume green, black or Oolong tea as well as red wine or any other beverages or foods containing green tea extract within three days before each blood sampling visit.
- For female patients: pregnancy or lactation.
- Blood transfusion within 30 days prior to enrollment.
- Subjects who are placed in an institution due to a judicial or official directive.
- For patients (treatment arm 1, additionally):
- Previous participation in a trial investigating sinecatechins in the treatment of external genital and perianal warts.
- Treatment of external genital warts 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 months prior to enrollment.
- Any current and/or recurrent pathologically relevant genital infections other than genital warts.
- Known allergies against any of the ingredients of the ointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Center Phase I (Phase IV/ USA) Study to Assess the Pharmacokinetic Profile of Topically Applied Veregen® 15% in Patients With External Genital and Perianal Warts Compared With Oral Intake of a Green Tea Beverage
This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
- Conditions
- Genital Warts, Perianal Warts
- Being tested
- Polyphenon E (Veregen) 15% ointment, Green Tea Beverage with defined catechin content
- Keywords
- green tea extract, Polyphenon E, Pharmacokinetics
- 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 (Veregen) 15% ointmentDrug
3 times daily application on genital and perianal warts over 7 days
Green Tea Beverage with defined catechin contentOther
3 times daily oral intake over 7 days
| Study group | Role | What they receive |
|---|---|---|
| oral intake of green tea beverage | Active comparator | Healthy volunteers are asked to drink a defined amount of green tea beverage over 7 days Receives: Other: Green Tea Beverage with defined catechin content |
| Polyphenon E 15% ointment | Experimental | 3 times daily application of Polyphenon E 15% ointment on genital and perianal warts over 7 days Receives: Drug: Polyphenon E (Veregen) 15% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of green tea catechins
Cmax, tmax, t1/2, AUC(0-t), and AUC of EGCg, EGC, ECg, and EC
Measured: Day 1/2 and Day 7/8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital WartsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charité Research Organisation GmbH
- Investigators
- Frank Wagner, Md, PD, Principal investigator, Charité Research Organisation, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082302
- Sponsor's protocol ID
- CT 1022
- Other IDs
- 2007-005432-88
- Status last verified
- Sep 2010
- First submitted
- 1 Feb 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center Phase I (Phase IV/ USA) Study to Assess the Pharmacokinetic Profile of Topically Applied Veregen® 15% in Patients With External Genital and Perianal Warts Compared With Oral Intake of a Green Tea Beverage
- ClinicalTrials.gov ID
- NCT01082302
- Acronym / sponsor ID
- CT 1022
- Conditions
- Genital Warts, Perianal Warts
- Keywords
- green tea extract, Polyphenon E, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Collaborators
- Charité Research Organisation GmbH
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Mar 2010 (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.
This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral intake of green tea beverage | Active comparator | Other: Green Tea Beverage with defined catechin contentHealthy volunteers are asked to drink a defined amount of green tea beverage over 7 days |
| Polyphenon E 15% ointment | Experimental | Drug: Polyphenon E (Veregen) 15% ointment3 times daily application of Polyphenon E 15% ointment on genital and perianal warts over 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects, 18 years of age or older at the time of enrollment. Subjects will be stratified by gender.
- Written informed consent.
- Ability to comply with the requirements of the study.
- Clinical diagnosis of external genital and perianal warts which can be located: in men: over the glans penis, foreskin, penis shaft, and scrotum; in women: on the vulva; in both gender: in the inguinal, perineal, and perianal areas.
- A total wart area of at least 100 mm² and a maximum of 2500 mm².
Key exclusion criteria (21 listed)
- Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration.
- Any current uncontrolled infection.
- Current known acute or chronic infection with Hepatitis virus B or C.
- Known Human immunodeficiency virus infection.
- Subjects with known history of chronic (diabetes, hypertension, gastritis, etc.) or consuming diseases (cancer, multiple sclerosis, etc.), chronic inflammation, or liver or renal insufficiency.
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 (Veregen) 15% ointment3 times daily application on genital and perianal warts over 7 days | Drug | Polyphenon E 15% ointment |
| Green Tea Beverage with defined catechin content3 times daily oral intake over 7 days | Other | oral intake of green tea beverage |
Primary outcome
Pharmacokinetic profile of green tea catechins
Time frame: Day 1/2 and Day 7/8
Cmax, tmax, t1/2, AUC(0-t), and AUC of EGCg, EGC, ECg, and EC
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 8 Sep 2010.
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Warts
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.
Frank Wagner, Md, PD principal investigator
Charité Research Organisation, Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyphenon E (Veregen) 15% ointment and Green Tea Beverage with defined catechin content in people with Genital Warts and Perianal Warts, run by MediGene at 1 site in Germany.
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 21 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 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pharmacokinetic profile of green tea catechins (time frame: Day 1/2 and Day 7/8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2010.