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

F

Fundación Eduardo Anitua

Status and phase

Not yet enrolling
Phase 3

Conditions

Lichen Sclerosus of Vulva

Treatments

Drug: Clobetasol Propionate
Drug: PRGF

Study type

Interventional

Funder types

Other

Identifiers

NCT05364515
BTIIMD-01-EC/217LIQUEN

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Conventional treatment
Active Comparator group
Description:
0.05% Clobetasol propionate
Treatment:
Drug: Clobetasol Propionate
PRGF
Experimental group
Description:
0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month)
Treatment:
Drug: Clobetasol Propionate
Drug: PRGF

Trial contacts and locations

0

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Central trial contact

Mikel Allende, PhD

Data sourced from clinicaltrials.gov

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