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

NCT ID: NCT07240389

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-31

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.

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.

Conditions

Vulvar Lichen Sclerosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Platelet-Rich Plasma (PRP) Treatment

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Clobetasol Propionate 0.05% Cream (Dermovate)

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Pimecrolimus Cream (Elidel)

Intervention Type: 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.

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milosz Pietrus

OTHER

Sponsor Role: lead

Responsible Party

Milosz Pietrus

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie

Krakow, Małopolska, Poland

Countries

Poland

Central Contacts

Milosz Pietrus, MD PhD

Role: CONTACT

milosz.pietrus@uj.edu.pl

+48 602 779 298

Other Identifiers

N41/DBS/001550

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UJ/2025/VULIS-3T

Identifier Type: -

Identifier Source: org_study_id