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Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.
Sponsor: Milosz Pietrus
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.
Official title: Evaluation of Therapeutic Outcomes in Vulvar Lichen Sclerosus Treated With Corticosteroids, Calcineurin Inhibitors, and Platelet-rich Plasma (PRP).
Key Details
Gender
FEMALE
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-12-01
Completion Date
2027-01-31
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Platelet-Rich Plasma (PRP) Treatment
Autologous platelet-rich plasma (5 ml) prepared using the Arthrex ACP Max™ Platelet-Rich Plasma System is injected subcutaneously and submucosally into clinically affected vulvar areas and sites of itching or pain. PRP is administered once at baseline following standard aseptic technique.
Clobetasol Propionate 0.05% Cream (Dermovate)
Participants apply clobetasol propionate 0.05% cream topically twice daily for the first 3 weeks, followed by once daily for the next 3 weeks. This regimen represents standard high-potency corticosteroid therapy for vulvar lichen sclerosus.
Pimecrolimus Cream (Elidel)
Participants apply pimecrolimus cream topically twice daily for 3 weeks, followed by once daily for the next 3 weeks. This regimen represents topical calcineurin inhibitor therapy for vulvar lichen sclerosus.
Locations (1)
Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie
Krakow, Małopolska, Poland