To gain insight in the pharmacokinetics of sinecathechins ointment 10% (Veregen) applied on healthy skin, using Raman micro-spectroscopy and chromatography of tape strips.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Cutaneous neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The levels of sinecathechins in the stratum corneum of the skin over time as
measured by Raman micro-spectroscopy.
Secondary outcome
The levels of sinecathechins in the stratum corneum of the skin over time as
measured by chromatography of tape strips.
Background summary
Sinecathechins ointment 10% (Veregen, formerly called Polyphenon E) is a
registered local therapy for genital warts. In the studies conducted for
registration, the ointment was applied 3 times a day (1). Apart from the idea
that there would be a continuous local presence of sinecathechins throughout
the day, a true rationale for this frequency of application was never provided.
Earlier pharmacokinetic studies for sinecathechins, an ingredient of green tea,
compared local application with sinecathechins ointment and the ingestion of
green tea. The levels of sinecathechins were measured in blood samples. These
studies showed that sinecathechins applied on skin do not lead to detectable
amounts of sinecathechins in blood, thus making pharmacokinetic analysis and
finding a rationale for frequency of application challenging (2).
The reason for the current study is to explore the pharmacokinetics of locally
applied sinecathechins in the skin.
When therapeutic ointments are applied on intact skin, the stratum corneum (top
layer of the skin) functions as a reservoir for the active ingredient of this
ointment. The active ingredient can then gradually be taken up into deeper
layers of the skin (epidermal and dermal layers respectively) (3). When
sufficient amounts of an active ingredient already are present in the stratum
corneum after one application a day, multiple applications might only increase
the chance of side effects without improving efficacy.
Minimizing the necessary frequency of application of topically applied
therapeutics is aimed at reducing cost, improving patients convenience,
compliance and reducing the chance of side effects.
If the current study shows that a continuous presence of sinecathechins in the
stratum corneum might be achieved with less than 3 applications a day, a dose
finding study in patients with genital warts is considered.
Study objective
To gain insight in the pharmacokinetics of sinecathechins ointment 10%
(Veregen) applied on healthy skin, using Raman micro-spectroscopy and
chromatography of tape strips.
Study design
To gain insight in the pharmacokinetics of sinecathechins ointment 10%
(Veregen) applied on healthy skin, using chromatography of tape strips.
Study burden and risks
It is possible that the iontment used causes local and transient irritation of
the skin.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000907-97-NL |
| CCMO | NL57691.018.16 |