NCT05836441招募中不适用
A Multicenter, Randomized, Open, Parallel Controlled Clinical Study Evaluating the Efficacy and Safety of Improved Phototherapy in Patients With Vitiligo
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- percentage reduction in vitiligo area
研究概览
简要总结
Vitiligo is a common acquired depigmentation skin and mucosal disease in dermatology, with or without white hair. Vitiligo with white hair is difficult to treat. Phototherapy and topical therapy are the first line treatment methods for vitiligo. The peripheral leukoplakia irradiation of phototherapy covers the central area of the leukoplakia and performs phototherapy on the edge of the leukoplakia and surrounding normal skin. This study aims to compare the efficacy and safety of peripheral leukoplakia ultraviolet family phototherapy and leukoplakia family combination in the treatment of vitiligo.
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
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Age: 5 years old and above
- •Gender: unlimited
- •Types of vitiligo: sporadic vitiligo, facial and neck vitiligo, mixed vitiligo, undetermined vitiligo
- •Vitiligo course: unlimited; ⑤ Vitiligo activity level: stable period; ⑥ At least one white spot meets the following four conditions simultaneously: Location: limited to the neck, trunk, and limbs (excluding hairless areas of hands and feet); There are no contraindications for the use of NB UVB phototherapy and topical tacrolimus; Area: 1cm2 < white spot area < 1% body surface area; The vellus hair in the white spot area is all white; ⑦ It is agreed to discontinue all forms of treatment that may change the study outcome during the study period, including western medicine, traditional Chinese medicine, traditional Chinese patent medicines and simple preparations, biological agents, etc., such as Dihydroketiazide, 8-M0P, osteotonic, angelica dahurica, etc; Willing and able to follow the visit and treatment plan.
排除标准
- •① Segmental vitiligo, generalized vitiligo, mucosal vitiligo, and acromegaly vitiligo;
- •Degree of vitiligo activity: progression, rapid progression
- •Kobner phenomenon or white spots located at the site of skin trauma, or other subjects requiring emergency intervention;
- •Subjects who are sensitive to or have contraindications to ultraviolet radiation (suffering from photosensitive diseases such as xeroderma pigmentosum, porphyria, Bloom syndrome, systemic lupus erythematosus, dysplastic nevus syndrome, dermatomyositis, etc.);
- •Subjects with a history of malignant tumors (including skin squamous cell carcinoma, melanoma or other skin and systemic malignant tumors);
- •Subjects with severe systemic diseases;
- •Subjects who are allergic to tacrolimus ointment or excipients in the ointment; ⑧ Subjects who have received oral or systemic medication (such as corticosteroids, cyclosporine, methotrexate, tacrolimus, etc.) aimed at controlling/improving vitiligo symptoms within 4 weeks prior to baseline, or who require systemic use of corticosteroids or immunosuppressants for other reasons;
- •⑨ Subjects who have received any optical therapy (including sunbathing) for vitiligo within 4 weeks prior to baseline;
- •⑩ Subjects who have received topical treatment aimed at controlling/improving vitiligo symptoms (such as glucocorticoids, calcineurin inhibitors, vitamin D3 derivatives, etc.) within 2 weeks prior to baseline.
- •⑪ Pregnant and lactating female subjects;
- •⑫ Subjects who are judged by researchers to be unable to implement treatment plans correctly;
- •⑬ Child subjects who cannot cooperate with phototherapy protective measures;
研究组 & 干预措施
White spot irradiation group
Active Comparator
Exposure to white patches
干预措施: Exposure to white patches (Radiation)
White spot edge irradiation group
Experimental
Exposure to edge of white patches and normal skin around white patches
干预措施: Exposure to edge of white patches and normal skin around white patches (Radiation)
结局指标
主要结局
percentage reduction in vitiligo area
时间窗: week12 after intervention
mean percentage reduction in vitiligo area from baseline to week 12
次要结局
- percentage reduction of leukotrichia in vitiligo region(week12 after intervention)
- NB-UVB dose(week12 after intervention)
研究者
研究点 (1)
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