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

NCT ID: NCT05364515

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-23
• Study Completion Date: 2024-02-15

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.

Conditions

Lichen Sclerosus of Vulva

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional treatment

0.05% Clobetasol propionate

Group Type: ACTIVE_COMPARATOR

Clobetasol Propionate

Intervention Type: DRUG

0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)

PRGF

0.05% Clobetasol propionate + PRGF

PRGF: 4 infiltrations (first two months) + topical administration (from third month)

Group Type: EXPERIMENTAL

PRGF

Intervention Type: DRUG

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)

Clobetasol Propionate

Intervention Type: DRUG

0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)

Interventions

PRGF

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)

Intervention Type: DRUG

Clobetasol Propionate

0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación Eduardo Anitua

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BTIIMD-01-EC/217LIQUEN

Identifier Type: -

Identifier Source: org_study_id