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

Lichen Sclerosus of Vulva Clinical Trial

— PRGF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05364515
• Other study ID #: BTIIMD-01-EC/217LIQUEN
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2022
• Est. completion date: October 2023

Study information

• Verified date: April 2022
• Source: Fundación Eduardo Anitua
• Contact: Mikel Allende, PhD
• Phone: +34945160653
• Email: mikel.allende[@]bti-implant.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Lichen Sclerosus of Vulva
• Vulvar Lichen Sclerosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency of recurrences at 6 and 8 months of treatment	Frequency of recurrences at 6 and 8 months of treatment	6 and 8 months
Secondary	Frequency of complications	Frequency of complications	1, 3, 6 and 8 months
Secondary	Platelet concentration	Platelet concentration measurement in whole blood and PRGF fraction	0 months
Secondary	Platelet recovery	Platelet enrichment (PRGF vs. whole blood)	0 months
Secondary	Presence of leukocyte	% of leukocyte in PRGF fraction	0 months