Injection of Autologous Stromal Vascular Fraction enriched lipoaspirate for the treatment of vulvar Lichen Sclerosus
- Conditions
- Vulvar Lichen Sclerosus
- Registration Number
- NL-OMON23776
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
•Postmenopausal women up to 80 years with ASA Physical Status Classification 0-1
•Histopathological confirmed diagnosis of lichen sclerosus
•Moderate or severe LS (IGA scale 3 or 4), therapy resistant to conventional therapy with highly potent topical steroids
(insufficient reduction in clinical symptoms and signs having used topical steroids for 6 months).
•Women with history of vulvar cancer or VIN in addition to lichen sclerosus.
•An oncological event in the patient’s history < 5 years ago.
•A known systemic disease that will impair wound healing (e.g. diabetes mellitus type I, known atherosclerosis with an event
that required hospitalization, collagen diseases, diseases of the skin, HIV).
•Systematic use of prednisone or other immunotherapy.
•Use of anticoagulant therapy.
•Smoking.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy is determined by the quantification of improvement in patient’s symptoms by improvement in quality-of-life and sexual functioning three months, six months and one year after injection of SVF enriched lipoaspirate. Quality of life is evaluated using the validated Dermatology Life Quality Index (DLQI) and resumption of sexual activity and quality of sexual functioning is evaluated using the validated Female Sexual Function Index (FSFI).
- Secondary Outcome Measures
Name Time Method The quantification of improvements in clinical signs and architectural changes by physical examination findings and improvements of histopathological parameters