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

NCT01082302 | Completed Phase 4

• 2 other identifiers: CT 10222007-005432-88
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

green tea extract; Polyphenon E; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of green tea catechins

  Cmax, tmax, t1/2, AUC(0-t), and AUC of EGCg, EGC, ECg, and EC

  Day 1/2 and Day 7/8

Study Arms (2)

oral intake of green tea beverage

ACTIVE COMPARATOR

Healthy volunteers are asked to drink a defined amount of green tea beverage over 7 days

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

Drug: Polyphenon E (Veregen) 15% ointment

Interventions

Polyphenon E (Veregen) 15% ointment DRUG

3 times daily application on genital and perianal warts over 7 days

Polyphenon E 15% ointment

Green Tea Beverage with defined catechin content OTHER

3 times daily oral intake over 7 days

oral intake of green tea beverage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MediGene: lead
• Charité Research Organisation GmbH: collaborator

Study Sites (1)

Charité Research Organisation

Berlin, D-10117, Germany

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

polyphenon E; green tea extract polyphenone E; Ointments

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Frank Wagner, Md, PD

  Charité Research Organisation, Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: March 8, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 8, 2010

Record last verified: 2010-09

Locations

DE (1)