Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Anogenital Warts

Thank you

Trial Information

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


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.

4. 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.

5. 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.

For patients (treatment arm 1, additionally):

6. 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

7. For women a negative pregnancy test and willingness to abstain from cohabitation
during the treatment phase.

8. For male patients willingness to abstain from cohabitation during the treatment
phase.

Exclusion Criteria:

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

9. Participation in an investigational trial within 30 days prior to enrollment and for
the whole study duration

10. Any current uncontrolled infection

11. Current known acute or chronic infection with Hepatitis virus B or C

12. Known Human immunodeficiency virus infection

13. Subjects with known history of instable diseases (diabetes, hypertension, etc.),
severe gastritis or consuming diseases (cancer, multiple sclerosis, etc.), or liver
or renal insufficiency.

14. Any chronic or acute condition including the skin, susceptible, in the opinion of the
investigator, of interfering with the evaluation of the drug effect

15. 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

16. 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

17. Systemic intake of immunosuppressive or immunomodulatory medication or vaccination
within 30 days prior to enrollment and for the whole study duration

18. Organ allograft recipient

19. 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

20. Subjects not willing to avoid the consumption of food or beverage containing
catechins, e.g. green, black or Oolong tea, red wine

21. For female patients: pregnancy or lactation

22. Blood transfusion within 30 days prior to enrollment

23. Subjects who are placed in an institution due to a judicial or official directive For
patients (treatment arm 1; additionally)

24. Previous participation in a trial investigating sinecatechins in the treatment of
external genital and perianal warts

25. Treatment of external genital warts within 14 days prior to enrollment and for the
whole study duration

26. Current infection with Herpes genitalis or history of Herpes genitalis infection
within the last 3 months prior to enrollment

27. Any current and/or recurrent pathologically relevant genital infections other than
genital warts

28. Known allergies against any of the ingredients of the ointment

29. Internal (vaginal, urethral, or rectal) warts requiring treatment For healthy
volunteers (treatment arm 2, additionally)

30. Known hereditary fructose intolerance, glucose-galactose malabsorption or
saccharase-isomaltase deficiency

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Systemic exposure of green tea catechin EGC

Outcome Description:

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 VeregenĀ® 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)

Outcome 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 VeregenĀ® 15%, and 0.5, 1, 2, 4, 6, 8, 10, 12, 14, and 24 hours afterwards.

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CT 1023

NCT ID:

NCT01490008

Start Date:

December 2011

Completion Date:

March 2012

Related Keywords:

  • Anogenital Warts
  • Condylomata Acuminata
  • Warts

Name

Location