Status:
COMPLETED
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
Lead Sponsor:
MediGene
Conditions:
Anogenital Warts
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized gree...
Eligibility Criteria
Inclusion
- 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 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.
- 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):
- 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
- For women a negative pregnancy test and willingness to abstain from cohabitation during the treatment phase.
- For male patients willingness to abstain from cohabitation during the treatment phase.
Exclusion
- 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 instable diseases (diabetes, hypertension, etc.), severe gastritis or consuming diseases (cancer, multiple sclerosis, etc.), 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
- 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
- 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
- Systemic intake of immunosuppressive or immunomodulatory 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 not willing to avoid the consumption of food or beverage containing catechins, e.g. green, black or Oolong tea, red wine
- 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 For patients (treatment arm 1; additionally)
- Previous participation in a trial investigating sinecatechins in the treatment of external genital and perianal warts
- Treatment of external genital warts within 14 days prior to enrollment and for the whole study duration
- Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 months prior to enrollment
- Any current and/or recurrent pathologically relevant genital infections other than genital warts
- Known allergies against any of the ingredients of the ointment
- Internal (vaginal, urethral, or rectal) warts requiring treatment For healthy volunteers (treatment arm 2, additionally)
- Known hereditary fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01490008
Start Date
December 1 2011
End Date
March 1 2012
Last Update
April 19 2012
Active Locations (1)
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1
CardioSec Clinical Reasearch GmbH
Erfurt, Germany, 99084