Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial, Controlled to Conventional Treatment, to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva

Conditions
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Lichen Sclerosus of Vulva

Intervention / Treatment
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* Drug: PRGF
* Drug: Clobetasol Propionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>0.05% Clobetasol propionate | Drug: Clobetasol Propionate<br>* 0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)<br>|
| Experimental: PRGF<br>0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month) | Drug: PRGF<br>* Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient. Four PRGF infiltrations (two weeks between each infiltration). Then, application of topical PRGF serum (on alternate basis)<br>Drug: Clobetasol Propionate<br>* 0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of quality of life measured by Skindex-29 index | Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome | 6 months | 
| Evolution of quality of life measured by Skindex-29 index | Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of quality of life measured by Skindex-29 index | Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome | 1 and 3 months | 
| Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS) | Values: from 0 to 40. Lower scores mean a better outcome. | 1, 3, 6 and 8 months | 
| Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS) | Values: from 0 to 40. Lower scores mean a better outcome. | 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) | 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 clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA) | Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA) | 1, 3, 6 and 8 months | 
| Frequency of recurrences at 6 and 8 months of treatment | Frequency of recurrences at 6 and 8 months of treatment | 6 and 8 months | 
| Frequency of complications | Frequency of complications | 1, 3, 6 and 8 months | 
| Platelet concentration | Platelet concentration measurement in whole blood and PRGF fraction | 0 months | 
| Platelet recovery | Platelet enrichment (PRGF vs. whole blood) | 0 months | 
| Presence of leukocyte | % of leukocyte in PRGF fraction | 0 months |