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

NCT07240389 | Not Yet Recruiting

• 2 other identifiers: UJ/2025/VULIS-3TN41/DBS/001550
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vulvar Lichen Sclerosus

Keywords

Vulvar Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• Change in DLQI (Dermatology Life Quality Index) Score

  The DLQI questionnaire assesses the impact of vulvar lichen sclerosus on patient quality of life. Scores range from 0 to 30, with higher scores indicating greater impairment. The study will measure the change in DLQI from baseline to 6 months across the three treatment groups.

  Baseline, 3 months, 6 months

Secondary Outcomes (1)

• Change in VDSS (Vulvar Disease Symptom Score)

  Baseline, 3 months, 6 months

Study Arms (3)

Platelet-Rich Plasma (PRP) Treatment

EXPERIMENTAL

Participants receive subcutaneous and submucosal injections of 5 ml autologous platelet-rich plasma (PRP) prepared using the Arthrex ACP Max™ system. PRP is injected into clinically affected vulvar areas and sites of itching or pain. Procedure performed once at study start. Outcomes are evaluated at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months.

Biological: Platelet-Rich Plasma (PRP) Treatment

Topical High-Potency Corticosteroid

ACTIVE COMPARATOR

Participants apply clobetasol propionate 0.05% cream (Dermovate) twice daily for the first 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months.

Drug: Clobetasol Propionate 0.05% Cream (Dermovate)

Topical Calcineurin Inhibitor

ACTIVE COMPARATOR

Participants apply pimecrolimus cream (Elidel) twice daily for 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months.

Drug: Pimecrolimus Cream (Elidel)

Interventions

Platelet-Rich Plasma (PRP) Treatment BIOLOGICAL

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.

Platelet-Rich Plasma (PRP) Treatment

Clobetasol Propionate 0.05% Cream (Dermovate) DRUG

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.

Topical High-Potency Corticosteroid

Pimecrolimus Cream (Elidel) DRUG

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.

Topical Calcineurin Inhibitor

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Only individuals who self-identify as women are eligible to participate, as the condition under study (vulvar lichen sclerosus) occurs exclusively in patients with vulvar anatomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any condition that, in the opinion of the investigator, would interfere with study participation, follow-up, or accurate interpretation of results.

Sponsors & Collaborators

• Milosz Pietrus: lead

Study Sites (1)

Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie

Krakow, Małopolska, 31-261, Poland

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Therapeutics; Clobetasol; pimecrolimus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Milosz Pietrus, MD PhD

CONTACT

+48 602 779 298; milosz.pietrus@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, investigators, or outcome assessors are masked to group assignment. No additional masking procedures are used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: This study uses a three-arm, parallel assignment model comparing commonly used first-line therapies for vulvar lichen sclerosus. Participants are allocated into one of three non-randomized groups: (1) platelet-rich plasma (PRP) injections, (2) high-potency topical corticosteroid cream, or (3) topical calcineurin inhibitor. Each group receives a distinct intervention, and outcomes are assessed over 6 months using validated symptom and quality-of-life questionnaires and histopathological evaluation. The open-label design reflects real-world clinical practice and allows direct comparison of the effectiveness of each treatment modality.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)