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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42887

Enrollment

Registered

2016-08-16

Start date

2016-11-14

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condyloma accuminata genital warts

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The levels of sinecathechins in the stratum corneum of the skin over time as measured by Raman micro-spectroscopy.	—

Secondary

Measure	Time frame
The levels of sinecathechins in the stratum corneum of the skin over time as measured by chromatography of tape strips.	—

Countries

Netherlands

Outcome results