To map microcirculation of the vulva and to evaluate the effects of vulvar LS and the application of topical corticosteroids on microcirculatory parameters with the use of incident dark field imaging (IDFI, Cytocam).
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in measurements of microcirculatory parameters of the vulva between
healthy women and women diagnosed with vulvar Lichen Sclerosus, before and
after treatment.
Secondary outcome
Not applicable
Background summary
Vulvar Lichen Sclerosis (LS) is a benign, chronic and progressive
dermatological condition characterized by inflammation, epithelial thinning and
distinctive dermal changes. The true etiology of this condition remains unknown
to date. Vulvar microcirculation is believed to significantly contribute to the
health of the vulva. Therefore, altered microcirculation could contribute to
the cause or be a consequence of the pathogenesis of vulvar LS.
Study objective
To map microcirculation of the vulva and to evaluate the effects of vulvar LS
and the application of topical corticosteroids on microcirculatory parameters
with the use of incident dark field imaging (IDFI, Cytocam).
Study design
An observational study.
Study burden and risks
Measurements will be performed which take about 15 minutes. The measurement
technique is painless and will cause no harm to the patient. Moreover, the
imaging probe will be covered with a sterile disposable cap. In healthy
volunteers this measurement is performed at a single timepoint, in patients the
measurement is repeated 2, 6 and 12 weeks achter the start of the treatment.
Patients will also fill out a questionnaire, at baseline and after 3 months.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with vulvar Lichen Sclerosus based on the presence of characteristic clinical manifestations
Patients who start treatment with topical corticosteroid therapy
Exclusion criteria
Cardiovascular disease
Other inflammatory (skin)disease
Other systemic illness
Medications that could influence the microcirculation
Design
Recruitment
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 |
|---|---|
| CCMO | NL60463.018.17 |