Evaluation of Therapeutic Outcomes in Vulvar Lichen Sclerosus Treated With Corticosteroids, Calcineurin Inhibitors, and Platelet-rich Plasma (PRP).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in DLQI (Dermatology Life Quality Index) Score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Platelet-Rich Plasma (PRP) Treatment (Biological)
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.
干预措施: Clobetasol Propionate 0.05% Cream (Dermovate) (Drug)
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.
干预措施: Pimecrolimus Cream (Elidel) (Drug)
结局指标
主要结局
Change in DLQI (Dermatology Life Quality Index) Score
时间窗: Baseline, 3 months, 6 months
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.
次要结局
- Change in VDSS (Vulvar Disease Symptom Score)(Baseline, 3 months, 6 months)
研究者
Milosz Pietrus
MD PhD
Jagiellonian University