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

This is an interventional treatment trial for Anogenital Warts Read More

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