Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
研究概览
简要总结
The purpose of this study is to investigate stress response pathways in tissues and melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and stress response activation in tissues and melanocytes from patients with vitiligo. Individuals with vitiligo will have punch biopsies to study stress response UPR activation and NF-κB signaling to test our hypothesis. In order to characterize differences between disease and normal states, a second arm of control individuals (Arm 2) will be recruited.
详细描述
Identifying a role for NF-κB signaling in vitiligo may improve therapies for this disfiguring disorder. Current treatments vary in effectiveness and may not always be long lasting cases. The NF-κB pathway and IL-6 itself are the target of several FDA approved drugs, thus opening new therapeutic avenues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for participation, subjects must meet all of the following criteria:
- •Must have a clinical exam consistent with and diagnosis of non-segmental vitiligo
- •Must be normally pigmented
- •No clinical presentation of vitiligo
排除标准
- •Outside of the specified age range
- •No clinical diagnosis of vitiligo
- •Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineurin inhibitors and/ or vitamin D analogs within 4 weeks of enrollment
- •Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment
- •History of keloids or hypertrophic scars
- •Patients with pacemakers or defibrillators or heart valves
- •Patients on Plavix, Warfarin or similar anticoagulation medicine
- •Pregnant females
- •Lactating women
- •Allergies or sensitivity to lidocaine or epinephrine
- •Outside of the specified age range
- •Abnormally pigmented at potential biopsy sites (non-vitiligo)
- •Clinical presentation of vitiligo
- •Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineuron inhibitors and/ or vitamin D analogs within 4 weeks of enrollment
- •Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment
- •History of keloids or hypertrophic scars
研究组 & 干预措施
Vitiligo Diagnosed Group
Clinically diagnosed with non-segmental vitiligo
干预措施: Punch Biopsy at a Lesional Site (Procedure)
Vitiligo Diagnosed Group
Clinically diagnosed with non-segmental vitiligo
干预措施: Punch Biopsy at a Non- Lesional site (Procedure)
Healthy Control Group
20 normally pigmented control subjects who are between the ages of 18 and 50
干预措施: Punch Biopsy at a Non- Lesional site (Procedure)
结局指标
主要结局
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
时间窗: 1 Year
次要结局
- T-test measures of expression levels in response to Vitiligo triggers(1 Year)