Status:
WITHDRAWN
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
Lead Sponsor:
Fundación Eduardo Anitua
Conditions:
Lichen Sclerosus of Vulva
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05364515
Start Date
December 23 2021
End Date
February 15 2024
Last Update
February 27 2025
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