Pharmacokinetic analysis of sinecathechins ointment 10% (Veregen) by means of Raman micro-spectroscopy in the skin of healthy volunteers

Completed

• Conditions: Condyloma accuminata; genital warts; 10047438; 10040899

• Registration Number: NL-OMON42887
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Inclusion criteria
- Age between 18 and 40 years
- Written informed consent

Exclusion Criteria

Exclusion criteria
- Extensive UV exposure in the last 14 days before study and/or expected during the study.
- Active skin disease and/or traumatic skin lesions including scars and tattoos on the forearms.
- Expected use of inflammation suppressing medicines (e.g. corticosteroids, NSAIDs) during the study.
- Use of systemic suppressing drugs (e.g. prednisone, methothrexate) prior to (4 weeks) the study and/or expected use during the study.
-Severe disorders within the last 6 months before study (e.g. cancer, acute cardiac or circularity disorders, HIV, infectious hepatitis)
-pregnancy or breastfeeding
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The levels of sinecathechins in the stratum corneum of the skin over time as<br /><br>measured by Raman micro-spectroscopy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The levels of sinecathechins in the stratum corneum of the skin over time as<br /><br>measured by chromatography of tape strips.</p><br>