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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lichen Sclerosus of Vulva
• Intervention / Treatment: Drug: Clobetasol Propionate; Drug: PRGF

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mikel Allende, PhD; Phone Number: 257 +34945160653; Email: mikel.allende@bti-implant.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment; 0.05% Clobetasol propionate	Drug: Clobetasol Propionate; 0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)
Experimental: PRGF; 0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month)	Drug: Clobetasol Propionate; 0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month); Drug: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: BTIIMD-01-EC/217LIQUEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No