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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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05364515
Study type Interventional
Source Fundación Eduardo Anitua
Contact Mikel Allende, PhD
Phone +34945160653
Email mikel.allende@bti-implant.es
Status Not yet recruiting
Phase Phase 3
Start date October 2022
Completion date October 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05953090 - VALOR: Vaginal Atrophy & Long-term Observation of Recovery N/A
Completed NCT03045172 - Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus N/A