Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-01-31

Summary

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.

• Phase: NA

Details

• Lead Sponsor: Milosz Pietrus
• Treatments: Clobetasol; pimecrolimus; Therapeutics