Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy. (VULIS-3T)

Evaluation of Therapeutic Outcomes in Vulvar Lichen Sclerosus Treated With Corticosteroids, Calcineurin Inhibitors, and Platelet-rich Plasma (PRP).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Biological: Platelet-Rich Plasma (PRP) Treatment; Drug: Clobetasol Propionate 0.05% Cream (Dermovate); Drug: Pimecrolimus Cream (Elidel)

Detailed Description

Vulvar lichen sclerosus (VLS) is a chronic, progressive inflammatory dermatosis that primarily affects the skin and mucosa of the vulva and perineal region. The condition is most common in postmenopausal women and may cause severe itching, burning, pain during sexual intercourse, and, over time, scarring or anatomical changes that can significantly impair daily functioning and quality of life. If untreated, VLS may also increase the risk of developing vulvar intraepithelial neoplasia (VIN) or squamous cell carcinoma.

Despite the chronic nature of the disease, there is still no universally accepted standard of care for first-line treatment. Topical corticosteroids (such as clobetasol propionate 0.05%) are considered the mainstay of therapy, while topical calcineurin inhibitors (e.g., pimecrolimus or tacrolimus) are often used as alternatives or adjuncts in resistant cases. In recent years, regenerative methods such as platelet-rich plasma (PRP) therapy have emerged as a promising option. PRP is an autologous preparation containing a high concentration of platelets and growth factors that can stimulate tissue repair, reduce inflammation, and improve mucosal regeneration.

This open-label, non-randomized clinical study aims to evaluate and compare the therapeutic efficacy and safety of three treatment modalities in women with histopathologically confirmed vulvar lichen sclerosus:

PRP injection therapy using the Arthrex ACP Max™ Platelet-Rich Plasma System,

Topical corticosteroid therapy with clobetasol propionate 0.05% cream, and

Topical calcineurin inhibitor therapy with pimecrolimus cream.

A total of 45 participants will be recruited and assigned to one of the three treatment arms (15 per group). Clinical symptoms and quality of life will be evaluated using two validated questionnaires - the Vulvar Disease Symptom Score (VDSS) and the Dermatology Life Quality Index (DLQI) - at baseline, 3 months, and 6 months after treatment initiation. At the 6-month follow-up, a small biopsy from the vulvar area will be performed to assess histopathological changes, particularly the density of inflammatory cells.

The results of this study may help determine whether platelet-rich plasma (PRP) therapy could represent an effective and safe alternative to conventional topical treatments. Ultimately, this research could contribute to the development of more individualized and evidence-based therapeutic strategies for women suffering from vulvar lichen sclerosus.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milosz Pietrus, MD PhD; Phone Number: +48 602 779 298; Email: milosz.pietrus@uj.edu.pl

Study Locations

• Poland
  • Małopolska
    • Krakow, Małopolska, Poland, 31-261
      • Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 30 to 80 years.
2. Clinical diagnosis of vulvar lichen sclerosus confirmed by histopathological examination.
3. Ability and willingness to provide written informed consent for participation in the study.
4. Ability to comply with study procedures, including questionnaire completion and follow-up visits at baseline, 3 months, and 6 months.

Exclusion Criteria:

1. Lack of written informed consent to participate in the study.
2. Prior treatment for vulvar lichen sclerosus (any systemic or topical therapy targeted at VLS).
3. Current or past vulvar neoplasia, including vulvar intraepithelial neoplasia (VIN) or vulvar carcinoma.
4. Other organic or dermatologic causes of vulvar symptoms that could interfere with diagnosis or outcome evaluation.
5. Any condition that, in the opinion of the investigator, would interfere with study participation, follow-up, or accurate interpretation of results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-Rich Plasma (PRP) Treatment; 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; 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.
Active Comparator: Topical High-Potency Corticosteroid; 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); 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.
Active Comparator: Topical Calcineurin Inhibitor; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VDSS (Vulvar Disease Symptom Score)	The VDSS evaluates symptom severity (itching, burning, pain, dyspareunia) associated with vulvar lichen sclerosus. The study assesses changes in total VDSS score over time to compare treatment effectiveness.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Milosz Pietrus

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Vulvar Lichen Sclerosus
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vulvar Diseases; Vulvar Lichen Sclerosus; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Betamethasone; Clobetasol; Therapeutics; pimecrolimus
• Other Study ID Numbers: UJ/2025/VULIS-3T; N41/DBS/001550 (Other Grant/Funding Number: Jagiellonian University Collegium Medicum)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the sensitive nature of vulvar biopsy samples and privacy considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No