Status:
UNKNOWN
Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Deka Medical, Inc.
Conditions:
Lichen Sclerosus Et Atrophicus of the Vulva
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. As measured by visual analogue scale (VAS) symptoms as itching, ...
Detailed Description
Lichen sclerosus (LS) is a vulvar dermatosis that changes the skin to white plaques (lichenification), less elasticity (sclerosis) and the tissue shows contractions with erosions and fissures. Gold st...
Eligibility Criteria
Inclusion
- Women aged \>18 years
- Women with histological assured or clinical confirmed Lichen sclerosus (Lichen score \> 5)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion
- Unable to read or understand study patient information document
- Patients with a legal guardian
- Refusal to participate
- Missing signed consent
- Pregnancy and lactation
- Proven bacterial or parasitic infection (clinical examination and/or vaginal wet mount)
- Vulvar cancer
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04107454
Start Date
January 1 2020
End Date
December 1 2021
Last Update
August 19 2021
Active Locations (1)
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1
Inselspital Frauenklinik
Bern, Switzerland, 3010