Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Global Subjective Score 75（GSS75） rate
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.
详细描述
This is a randomized, open-labeled, assessor-blind, parallel control study. 134 enrolled patients will be randomized to apply either topical 0.1% corticosteroid mometasone furoate(MMF) ointment or photodynamic therapy.
For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive CO2 fractional laser before photodynamic therapy, while the other side will receive photodynamic therapy only.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 (inclusive), female patients;
- •present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination;
- •Volunteer to participate in this study and sign an informed consent form.
排除标准
- •Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.;
- •Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.;
- •Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis;
- •People with porphyria or porphyria allergy;
- •Suffer from psychiatric diseases, such as schizophrenia, etc.;
- •Those who are undergoing systemic treatment due to malignant tumor diseases, such as cervical cancer;
- •It is confirmed by laboratory pathogenic screening to have syphilis, HIV, and other sexually transmitted diseases or viral hepatitis;
- •Patients with current bacterial or fungal infections in the anus and genitals;
- •Women of childbearing age who have pregnancy plans, are pregnant, or are breastfeeding during the observation period of this study;
- •Patients who are systematically using glucocorticoids, immunosuppressants, and anticoagulants;
- •Use glucocorticoids for topical or local injection and calcineurin inhibitors for topical use within 4 weeks;
- •Those who are allergic to 5-aminolevulinic acid or its base, mometasone furoate or its base;
- •Other situations that the investigator considers inappropriate to participate in the clinical study.
研究组 & 干预措施
Photodynamic treatment monotherapy or combined with CO2 fractional laser
For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive 5-aminolevulinic acid (5-ALA) with a red light illumination(80mW/cm2, and 120J/ cm2); while the other side will receive CO2 fractional laser(parameter: 20mm *20mm, spot coverage rate 10%, and 18-25mJ/cm2) before photodynamic therapy. Treating area should cover 0.5cm beyond the visible boundary of the lesion. In total 6 therapies will be given for each patient, with 14±3d intervals.
干预措施: CO2 fractional laser (Device)
Photodynamic treatment monotherapy or combined with CO2 fractional laser
For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive 5-aminolevulinic acid (5-ALA) with a red light illumination(80mW/cm2, and 120J/ cm2); while the other side will receive CO2 fractional laser(parameter: 20mm *20mm, spot coverage rate 10%, and 18-25mJ/cm2) before photodynamic therapy. Treating area should cover 0.5cm beyond the visible boundary of the lesion. In total 6 therapies will be given for each patient, with 14±3d intervals.
干预措施: 5-aminolevulinic acid (5-ALA) with red light illumination (Combination Product)
Mometasone furoate cream
Mometasone furoate cream (0.1%) for topical application, frequency: once daily, 5 days/week, for the first month; once every other day, for the second month; twice a week for the third month; the area of application should cover 0.5cm beyond the visible boundary of the lesion.
干预措施: Mometasone furoate (MMF) 0.1% ointment (Drug)
结局指标
主要结局
Global Subjective Score 75（GSS75） rate
时间窗: 2 weeks after the final treatment
GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable). GSS75 rate is the rate of patients achieving GSS75.
次要结局
- Lichen Sclerosus Area （LSA）(2 weeks, 12 weeks, 6 months, 12months after the final treatment)
- Recurrence rate(6 months, 12 months after the final treatment)
- Global Subjective Score 75（GSS75）(12 weeks after the final treatment)
- Dermoscope Area Score （DAS）(2 weeks, 12 weeks, 6 months, 12 months after the final treatment)
- incidence of adverse events(up to 12 months)
- Global Objective Score（GOS）(2 weeks, 12 weeks, 6 months, 12 months after the final treatment)
- Quality of Life（QOL）(2 weeks, 12 weeks, 6 months, 12 months after the final treatment)