Clinical trial to assess the efficacy of Plasma Rich in Growth Factors (PRGF®) in the treatment of vulvar lichen sclerosus atrophicus

Phase 1

• Conditions: Vulvar Lichen Sclerosus et atrophicus; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-006474-23-ES
• Lead Sponsor: BTI I MAS D S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

- Age> 18 years
- Woman with symptoms associated with LEA confirmed with histological study
- Spend 1 month without previous treatment in the affected area as a washing period
- Availability of observation during the treatment period
- Signature of the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Somatic disease in acute state
- Infection in the area of ??intervention or active systemic infection
- History of cancerous or precancerous lesions in the area of
intervention
- In active treatment with other local treatments in the intervention area
- In active treatment with immunosuppressants and / or anticoagulants
- History of allergies to blood derivatives
- Previous diagnosis of coagulopathies
- Regular and continued treatment with NSAIDs
- Positive markers for HCV, AfHBs, HIV-I / II or TP
- Pregnancy or women of childbearing potential not taking contraceptive measures
- Lactating women
- Treatment with monoclonal antibodies
- Any inability to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Analyze the efficacy of PRGF® in the evolution of quality of life of patients with vulvar lichen sclerosus et atrophicus at six and<br>eight months.;Secondary Objective: 1. Study the evolution of dermatological quality of life at 1 and 3 months.<br>2. Study the clinical evolution at 1, 3, 6 and 8 months.<br>3. Study the evolution of pain at 1, 3, 6 and 8 months.<br>4. Study the global impression of improvement at 1, 3, 6 and 8 months.<br>5. Characterization of blood hematological parameters and PRGF®.<br>6. Frequency of recurrences at 6 and 8 months of treatment.<br>7. Evaluate the safety of PRGF®.;Primary end point(s): Evolution of quality of life at 6 and 8 months measured through the Skindex-29 index: validated scale referring to dermatological diseases;Timepoint(s) of evaluation of this end point: 6 and 8 months