Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
- Conditions
- Lichen Sclerosus of Vulva
- Interventions
- Registration Number
- NCT05364515
- Lead Sponsor
- Fundación Eduardo Anitua
- Brief Summary
Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment.
Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 30
- Age >18 years
- Woman with symptoms associated with LEA confirmed by histological study
- Being 1 month without prior treatment in the affected area as a washing period
- Availability of observation during the treatment period
- Signature of the informed consent
- Acute somatic disease
- Infection in the intervention area or active systemic infection
- History of cancerous or precancerous lesions in the intervention area
- In active treatment with other local treatments in the intervention area
- Under active treatment with immunosuppressants and/or anticoagulants
- History of allergies to blood derivatives
- Previous diagnosis of coagulopathies
- Regular and continuous treatment with NSAIDs
- Positive markers for HCV, AfHBs, HIV-I/II or PT
- Pregnancy or women of childbearing age not taking contraceptive measures
- Lactating women
- Treatment with monoclonal antibodies
- Liver failure
- Any inability to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRGF PRGF 0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month) Conventional treatment Clobetasol Propionate 0.05% Clobetasol propionate PRGF Clobetasol Propionate 0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month)
- Primary Outcome Measures
Name Time Method Evolution of quality of life measured by Skindex-29 index 8 months Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
- Secondary Outcome Measures
Name Time Method Presence of leukocyte 0 months % of leukocyte in PRGF fraction
Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA) 1, 3, 6 and 8 months Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
Frequency of complications 1, 3, 6 and 8 months Frequency of complications
Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS) 1, 3, 6 and 8 months Values: from 0 to 40. Lower scores mean a better outcome.
Frequency of recurrences at 6 and 8 months of treatment 6 and 8 months Frequency of recurrences at 6 and 8 months of treatment
Evolution of quality of life measured by Skindex-29 index 1 and 3 months Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I) 1, 3, 6 and 8 months Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
Platelet recovery 0 months Platelet enrichment (PRGF vs. whole blood)
Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS) 1, 3, 6 and 8 months Values: from 0 to 40. Lower scores mean a better outcome.
Platelet concentration 0 months Platelet concentration measurement in whole blood and PRGF fraction