Study of vulval lichen sclerosus treatment by adipose tissue associated with autologous platelet-rich plasma
- Conditions
- Vulval lichen sclerosusMedDRA version: 19.1 Level: LLT Classification code 10047761 Term: Vulval lichen sclerosus et atrophicus System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-003952-63-ES
- Lead Sponsor
- Instituto de Investigación Sanitaria La Fe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method