Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage

This study has been completed.
Sponsor:
Collaborator:
Charité Research Organisation
Information provided by:
MediGene
ClinicalTrials.gov Identifier:
NCT01082302
First received: February 1, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Genital Warts
Perianal Warts
Drug: Polyphenon E (Veregen) 15% ointment
Other: Green Tea Beverage with defined catechin content
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MediGene:

Primary Outcome Measures:
  • Pharmacokinetic profile of green tea catechins [ Time Frame: Day 1/2 and Day 7/8 ] [ Designated as safety issue: No ]
    Cmax, tmax, t1/2, AUC(0-t), and AUC of EGCg, EGC, ECg, and EC


Enrollment: 43
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral intake of green tea beverage
Healthy volunteers are asked to drink a defined amount of green tea beverage over 7 days
Other: Green Tea Beverage with defined catechin content
3 times daily oral intake over 7 days
Experimental: Polyphenon E 15% ointment
3 times daily application of Polyphenon E 15% ointment on genital and perianal warts over 7 days
Drug: Polyphenon E (Veregen) 15% ointment
3 times daily application on genital and perianal warts over 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For both subject groups (treatment arms 1 + 2):

  1. Male and female subjects, 18 years of age or older at the time of enrollment. Subjects will be stratified by gender.
  2. Written informed consent.
  3. Ability to comply with the requirements of the study.

    For patients (treatment arm 1, additionally):

  4. 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.
  5. A total wart area of at least 100 mm² and a maximum of 2500 mm².
  6. 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).

Exclusion Criteria:

For both subject groups (treatment arms 1 + 2):

  1. Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration.
  2. Any current uncontrolled infection.
  3. Current known acute or chronic infection with Hepatitis virus B or C.
  4. Known Human immunodeficiency virus infection.
  5. Subjects with known history of chronic (diabetes, hypertension, gastritis, etc.) or consuming diseases (cancer, multiple sclerosis, etc.), chronic inflammation, or liver or renal insufficiency.
  6. Any chronic or acute condition including the skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect.
  7. Laboratory data above the upper normal range.
  8. 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.
  9. Systemic intake of immunosuppressive or immuno-modulatory medication or vaccination within 30 days prior to enrollment and for the whole study duration.
  10. Organ allograft recipient.
  11. 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.
  12. For female patients: pregnancy or lactation.
  13. Blood transfusion within 30 days prior to enrollment.
  14. Subjects who are placed in an institution due to a judicial or official directive.

    For patients (treatment arm 1, additionally):

  15. Previous participation in a trial investigating sinecatechins in the treatment of external genital and perianal warts.
  16. Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration.
  17. Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 months prior to enrollment.
  18. Any current and/or recurrent pathologically relevant genital infections other than genital warts.
  19. Known allergies against any of the ingredients of the ointment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082302

Locations
Germany
Charité Research Organisation
Berlin, Germany, D-10117
Sponsors and Collaborators
MediGene
Charité Research Organisation
Investigators
Principal Investigator: Frank Wagner, Md, PD Charité Research Organisation, Berlin
  More Information

No publications provided

Responsible Party: Dr. Petra Weyrauch, MediGene
ClinicalTrials.gov Identifier: NCT01082302     History of Changes
Other Study ID Numbers: CT 1022, 2007-005432-88
Study First Received: February 1, 2010
Last Updated: September 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by MediGene:
green tea extract
Polyphenon E
Pharmacokinetics

Additional relevant MeSH terms:
Warts
DNA Virus Infections
Neoplasms
Papillomavirus Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014