Anogenital WartsPhase 1NCT01490008
Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers
A Phase 1 study testing Veregen and Green Tea in people with Anogenital Warts, run by MediGene at 1 site in Germany.
Trial summary
Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized green tea beverage in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anogenital Warts
- What is being tested?
- Veregen and Green Tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Mar 2012
- Phase
- Phase 1
- 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 male patients and partners of male patients who are of child-bearing potential: use of two methods of effective contraception (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant or sterilization plus condom during the treatment period is mandatory.
- For women a negative pregnancy test and the willingness to use two methods of effective contraception (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant or sterilization plus condom during the treatment period is mandatory.
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- 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
- For women a negative pregnancy test and willingness to abstain from cohabitation during the treatment phase.
- For male patients willingness to abstain from cohabitation during the treatment phase.
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 instable diseases (diabetes, hypertension, etc.), severe gastritis or consuming diseases (cancer, multiple sclerosis, etc.), 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
- Subject with any of the following:
- quantitative hematology values deviating more than 20% of upper or lower normal values
- clinical chemistry except electrolytes and liver enzymes deviating more than 50% of upper or lower normal values
- liver enzymes exceeding twice the upper limit of normal range (ULN)
- serum electrolytes deviating more than 20% of upper or lower normal values
- abnormal results in urine supported by clinical evidence
- laboratory values out of normal range and showing corresponding clinical signs or symptoms
- 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 famcyclovir and valcyclovir
- Systemic intake of immunosuppressive or immunomodulatory 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 not willing to avoid the consumption of food or beverage containing catechins, e.g. green, black or Oolong tea, red wine
- 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 14 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
- Internal (vaginal, urethral, or rectal) warts requiring treatment For healthy volunteers (treatment arm 2, additionally)
- Known hereditary fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center Triqal to Evaluate Systemic Exposure of Catechins From Commercially Available, Topically Applied Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers
Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized green tea beverage in healthy subjects.
Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin exposure following dermal administration in the patient group will only be calculated if sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations.
Read more
If applicable, a safety margin for ointment use might need to be established with respect to intolerable systemic exposures of catechins following application of Veregen® ointment.
In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg three times daily: in the morning, at midday, and in the evening on the defined anogenital administration area (total dose of 750 mg/d) for one week .
In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea beverage ("Lipton® Green Limone" distributed by PepsiCo Deutschland GmbH, Neu-Isenburg, Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500 mL/d) for one week.
Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24 hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first dosing).
To avoid any influence on overall systemic catechin exposure deriving from any other source than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages known to containing catechins (a list of all prohibited and allowed foods and beverages will be provided to all subjects).
For concomitant medication, only paracetamol and oral contraceptives are allowed.
- Conditions
- Anogenital Warts
- Being tested
- Veregen, Green Tea
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeregenDrug
Patients in treatment arm 1 will apply Veregen® 15% ointment (approved commercial source in US) in a total of 750 mg/day for one week, corresponding to application of maximal about 106,9 mg catechins/d, thereof maximal 81 mg ECGg per day). Patients will be instructed to apply fix portions of 250 mg three times daily on the defined anogenital administration area.
Green TeaOther
Healthy volunteers in treatment arm 2 will drink "Lipton® Green Limone" in a total of 1500 mL/d for one week, in portions of 500 mL three times daily after the meals
| Study group | Role | What they receive |
|---|---|---|
| Veregen | Experimental | Veregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d) Receives: Drug: Veregen |
| Tea | Active comparator | "Lipton® Green Limone", a green tea beverage; oral intake of 500 mL green tea, 3 times daily (total dose on 1500 mL/d) Receives: Other: Green Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic exposure of green tea catechin EGC
The primary objective of this trial is to investigate the systemic exposure, and, if possible, the plasma concentrations and pharmacokinetics of green tea catechin EGCg after topically applied Veregen® 15% ointment in patients with external genital warts and that following oral intake of commercially available green tea beverage by healthy subjects.
On the sampling Days 1/2 and 7/8, blood samples of 3 mL each will be collected (non-fasting condition) at specified time points (see above)
Measured: At time points 0, i.e. prior to the morning ingestion of 500 mL of commercial green tea beverage or the morning application of 250 mg Veregen® 15%, and 0.5, 1, 2, 4, 6, 8, 10, 12, 14, and 24 hours afterwards.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anogenital 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490008
- Sponsor's protocol ID
- CT 1023
- Other IDs
- 2011-004857-20
- Status last verified
- Apr 2012
- First submitted
- 2 Dec 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center Triqal to Evaluate Systemic Exposure of Catechins From Commercially Available, Topically Applied Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01490008
- Acronym / sponsor ID
- CT 1023
- Conditions
- Anogenital Warts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Dec 2011 (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.
Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized green tea beverage in healthy subjects.
Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin exposure following dermal administration in the patient group will only be calculated if sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations.
If applicable, a safety margin for ointment use might need to be established with respect to intolerable systemic exposures of catechins following application of Veregen® ointment.
In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg three times daily: in the morning, at midday, and in the evening on the defined anogenital administration area (total dose of 750 mg/d) for one week .
In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea beverage ("Lipton® Green Limone" distributed by PepsiCo Deutschland GmbH, Neu-Isenburg, Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500 mL/d) for one week.
Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24 hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first dosing).
To avoid any influence on overall systemic catechin exposure deriving from any other source than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages known to containing catechins (a list of all prohibited and allowed foods and beverages will be provided to all subjects).
For concomitant medication, only paracetamol and oral contraceptives are allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veregen | Experimental | Drug: VeregenVeregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d) |
| Tea | Active comparator | Other: Green Tea"Lipton® Green Limone", a green tea beverage; oral intake of 500 mL green tea, 3 times daily (total dose on 1500 mL/d) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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.
- For male patients and partners of male patients who are of child-bearing potential: use of two methods of effective contraception (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant or sterilization plus condom during the treatment period is mandatory.
- For women a negative pregnancy test and the willingness to use two methods of effective contraception (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant or sterilization plus condom during the treatment period is mandatory.
Key exclusion criteria (29 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 instable diseases (diabetes, hypertension, etc.), severe gastritis or consuming diseases (cancer, multiple sclerosis, etc.), 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 |
|---|---|---|
| VeregenPatients in treatment arm 1 will apply Veregen® 15% ointment (approved commercial source in US) in a total of 750 mg/day for one week, corresponding to application of maximal about 106,9 mg catechins/d, thereof maximal 81 mg ECGg per day). Patients will be instructed to apply fix portions of 250 mg three times daily on the defined anogenital administration area. | Drug | Veregen |
| Green TeaHealthy volunteers in treatment arm 2 will drink "Lipton® Green Limone" in a total of 1500 mL/d for one week, in portions of 500 mL three times daily after the meals | Other | Tea |
Primary outcome
Systemic exposure of green tea catechin EGC
Time frame: At time points 0, i.e. prior to the morning ingestion of 500 mL of commercial green tea beverage or the morning application of 250 mg Veregen® 15%, and 0.5, 1, 2, 4, 6, 8, 10, 12, 14, and 24 hours afterwards.
The primary objective of this trial is to investigate the systemic exposure, and, if possible, the plasma concentrations and pharmacokinetics of green tea catechin EGCg after topically applied Veregen® 15% ointment in patients with external genital warts and that following oral intake of commercially available green tea beverage by healthy subjects. On the sampling Days 1/2 and 7/8, blood samples of 3 mL each will be collected (non-fasting condition) at specified time points (see above)
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 19 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Veregen and Green Tea in people with Anogenital 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 10 inclusion and 29 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 19 Apr 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Systemic exposure of green tea catechin EGC (time frame: At time points 0, i.e. prior to the morning ingestion of 500 mL of commercial green tea beverage or the morning application of 250 mg Veregen® 15%, and 0.5, 1, 2, 4, 6, 8, 10, 12, 14, and 24 hours afterwards.). 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 19 Apr 2012.