Injection of Autologous Stromal Vascular Fraction enriched lipoaspirate for the treatment of vulvar Lichen Sclerosus - a pilot study

• Conditions: Chronic inflammatory dermatosis; chronic skin disease; lichen sclerosus; 10014982; 10040795

• Registration Number: NL-OMON48736
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Postmenopausal women up to 80 years with ASA Physical Status Classification 0-1
- Histopathological confirmed diagnosis of lichen sclerosus
- Moderate or severe lichen sclerosus (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).

Exclusion Criteria

- Women with history of vulvar cancer or vulva intraepitheliale neoplasie (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
<p>The primary objective of this study is to perform a pilot-study on the efficacy<br /><br>and safety of autologous injections of SVF enriched lipoaspirate for the<br /><br>treatment of therapy-resistant vulvar lichen sclerosus. Efficacy is determined<br /><br>by the quantification of improvement in patient*s symptoms by improvement in<br /><br>quality-of-life and sexual functioning three months, six months and one year<br /><br>after injection of SVF enriched lipoaspirate. Quality of life is evaluated<br /><br>using the validated Dermatology Life Quality Index (DLQI) and resumption of<br /><br>sexual activity and quality of sexual functioning is evaluated using the<br /><br>validated Female Sexual Function Index (FSFI). </p><br>