Chronic inflammatory dermatosis chronic skin disease lichen sclerosus
Conditions
Interventions
All patients will receive autologous SVF enriched lipoaspirate: 20 ml of
lipoaspirate will be added to 2 ml of SVF resulting in a total of 22 ml of SVF
enriched aspirate to be injected in the vulvar
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to perform a pilot-study on the efficacy and safety of autologous injections of SVF enriched lipoaspirate for the treatment of therapy-resistant vulvar lichen sclerosus. 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
| Measure | Time frame |
|---|---|
| Secondary objective is the quantification of improvements in clinical signs and architectural changes by physical examination findings and improvements of histopathological parameters. To date, no agreed-on standard exists to measure lichen sclerosus disease severity for use in clinical practice or research trials. For this pilot study we developed a non standardized severity scale, based on the preliminary outcomes of an international expert consensus exercise for item generation for the development of a future adult vulvar lichen sclerosus severity scale. Each parameter is scored by a five point Investigator Global Assessment (IGA) scale for severity of disease (0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease) Clinical signs in lichen sclerosus include parameters on extent of disease, erosions, excoriations or ulcerations, white lesions, hyperkeratosis,, lichenification, (loss of) elasticity and sclerosis. Architectural changes include caliber and elasticity of vaginal introitus (narrowing of introitus), clitoris burying degree (clitoral hood fusion), labial resorption/fusion, fusion below the clitoris,(urethral occlusion), posterior commisure bands (fourchette webs). In order to reduce observer bias, standardised digital photographs are made before and at three months, six months and one year after SVF enriched lipofilling treatment. These digital registrations will be assessed by a panel of three independent expert consultant gynaecologists from the University Medical Center Groningen, whom are blinded-for-time before and after treatment. To compare histological modi*cations of the vulvar skin before and after injection of SVF enriched lipofilling and assess the mechanism of SVF enriched lipofilling therapy, biopsies are taken at three times on the same locations of the perivulvar area: pre-operative (lichen sclerosus affected vulvar skin), 3 months postoperative and 1 year postoperative. Histological p | — |
Countries
Netherlands
Outcome results
None listed