Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin condition that affects the vulvar area, often causing itching, burning, and pain, and may lead to scarring and narrowing of the vaginal opening. The condition significantly reduces the quality of life and may increase the risk of cancerous changes if left untreated.
This clinical study aims to evaluate and compare three commonly used treatment methods for women with biopsy-confirmed vulvar lichen sclerosus:
Topical corticosteroid therapy (clobetasol propionate 0.05%),
Topical calcineurin inhibitor therapy (pimecrolimus), and
Platelet-rich plasma (PRP) injections, which use the patient's own blood plasma rich in growth factors to support tissue healing.
A total of 45 participants aged 30 to 80 years will be enrolled and assigned to one of the three treatment groups. The effectiveness of therapy will be assessed using standardized questionnaires about symptoms and quality of life, as well as microscopic evaluation of tissue samples before and after treatment.
The study seeks to determine whether platelet-rich plasma (PRP) can serve as a safe and effective first-line treatment option for vulvar lichen sclerosus and to improve our understanding of the best therapeutic approaches for this chronic disease.
Age 30 to 80 years.
Clinical diagnosis of vulvar lichen sclerosus confirmed by histopathological examination.
Ability and willingness to provide written informed consent for participation in the study.
Ability to comply with study procedures, including questionnaire completion and follow-up visits at baseline, 3 months, and 6 months.
Lack of written informed consent to participate in the study.
Prior treatment for vulvar lichen sclerosus (any systemic or topical therapy targeted at VLS).
Current or past vulvar neoplasia, including vulvar intraepithelial neoplasia (VIN) or vulvar carcinoma.
Other organic or dermatologic causes of vulvar symptoms that could interfere with diagnosis or outcome evaluation.
Milosz Pietrus
Lead sponsor
Jagiellonian University
Sponsor institution