Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Not Enrolling
Both
Genital Warts, Perianal Warts

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetic profile of green tea catechins

Outcome Description:

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

Outcome Time Frame:

Day 1/2 and Day 7/8

Safety Issue:

No

Principal Investigator

Frank Wagner, Md, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Research Organisation, Berlin

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CT 1022

NCT ID:

NCT01082302

Start Date:

January 2010

Completion Date:

August 2010

Related Keywords:

  • Genital Warts
  • Perianal Warts
  • green tea extract
  • Polyphenon E
  • Pharmacokinetics
  • Condylomata Acuminata
  • Warts

Name

Location