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

NCT05364515 | Withdrawn Phase 3 DMC

• 1 other identifier: BTIIMD-01-EC/217LIQUEN
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Evolution of quality of life measured by Skindex-29 index

  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)

  1, 3, 6 and 8 months

• Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)

  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)

  1, 3, 6 and 8 months

• Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)

  1, 3, 6 and 8 months

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

0.05% Clobetasol propionate

Drug: Clobetasol Propionate

PRGF

EXPERIMENTAL

0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month)

Drug: PRGF; Drug: Clobetasol Propionate

Interventions

PRGF 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)

PRGF

Clobetasol Propionate DRUG

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

Conventional treatment; PRGF

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Eduardo Anitua: lead

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 6, 2022
• Study Start: December 23, 2021
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share