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

Official title

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

Overview

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.

Interventions

• 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.
• 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.
• 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.

Primary outcome measures

• Change in DLQI (Dermatology Life Quality Index) Score [Time frame: Baseline, 3 months, 6 months]

Secondary outcome measures (1)

• Change in VDSS (Vulvar Disease Symptom Score) [Time frame: Baseline, 3 months, 6 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Poland · 1 center

• Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie — Krakow

Identifiers

NCT: NCT07240389 · UJ/2025/VULIS-3T · N41/DBS/001550

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗