Vulval lichen sclerosus MedDRA version: 19.1 Level: LLT Classification code 10047761 Term: Vulval lichen sclerosus et atrophicus System Organ Class: 100000004858
Conditions
Interventions
Product Name: Autologous fat graft associatte with autologous platelet rich plasma (PRP)
Pharmaceutical Form: Injection
INN or Proposed INN: Platelet-rich plasma (PRP)
Sponsors
Instituto de Investigación Sanitaria La Fe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult women between 18 and 70 years old Patients with clear clinical and / or histological diagnosis of lichen sclerosus Vulvar biopsy existence at some point in patient’s medical history to exclude malignant or pre-malignant disease Moderate or severe disease at genital level Patients who have had topical treatment for at least three months with 0.05% clobetasol propionate. Informed consent previously signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Pregnant or lactating women Alcoholic patients Patients with malignant disease diagnosed in the last 5 years Patients infected with HIV, HBV and HCV virus Injecting drug users Patients with serious active infectious diseases. Patients with allergy or intolerance recognized for any of the above treatments Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, Psoriasis, Eczema). Patients with unrealistic expectations regarding the ultimate benefits of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the improvement in the elasticity of the fibrosis plaques of patients affected by vulval lichen sclerosus after two infiltrations of fat tissue and autologous platelet-rich plasma.;Secondary Objective: Study of vulvar subunits structural improvement; Evaluate structural improvement in the vulvular areas treated; Analysis of the fibrosis and inflammation improvement at 6 months of the first infiltration and 3 months of the second infiltration;To evaluate if there is symptoms improvement at the month, 3 months, 6 months and 12 months of the first infiltration and at 3 and 9 months of the second infiltration;Examine if there is an improvement in quality of life;Determine whether the beneficial effects at the level of symptom reduction following infiltration of the patient's own fat tissue associated with platelet-rich plasma are maintained in the long term (for at least one year from the first infiltration);Later use of the clinical and pain scale of this study in studies of vulvar lichen sclerosus with greater number of patients;Evaluate treatment-derived adverse events during the first year after first infiltration by CRD collection.;Primary end point(s): Elasticity of fibrosis plaques in the affected vulvar area;Timepoint(s) of evaluation of this end point: 1 month, 3 months, 6 months and 12 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Structural improvement of vulvar subunits, histological improvement, improvement in quality of life, improvement of clinical and symptoms, and improvement in scores on clinical scale, pain scale, pruritus scale, and IFS ( Index of sexual function) of Rosen.;Timepoint(s) of evaluation of this end point: 1 month, 3 months, 6 months and 12 months after treatment. | — |
Countries
Spain
Contacts
Public ContactJose Maria Millan Salvador
Instituto de Investigación Sanitaria La Fe
Outcome results
None listed