A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of skin repigmentation after 12 weeks
研究概览
简要总结
The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.
The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.
Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.
The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients 18 years and older with the diagnosis of Vitiligo.
排除标准
- •Female patients currently pregnant or lactating
- •Female patients with plans to come pregnant during the next 3 months
- •Allergic reactions to topical or oral prostaglandins
- •Uncontrolled skin disease
- •History of glaucoma
- •Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation.
- •Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation
- •Inability or unwillingness of subject or legal guardian/representative to give
研究组 & 干预措施
Area 1: Excimer laser, bimatoprost, and microneedling
干预措施: Bimatoprost (Drug)
Area 1: Excimer laser, bimatoprost, and microneedling
干预措施: Excimer laser (Device)
Area 1: Excimer laser, bimatoprost, and microneedling
干预措施: Microneedling with a dermaroller (Device)
Area 2: Excimer laser
干预措施: Excimer laser (Device)
结局指标
主要结局
Percentage of skin repigmentation after 12 weeks
时间窗: Post treatment (at week 12)
A blinded outcome accessor will compare photographs of patients before and after treatment.
Number of patients with perceived improvement after 12 weeks.
时间窗: Week 12
Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs.
次要结局
- Change in quality of life(Baseline and post treatment approximately 12 weeks)
研究者
Joni Mazza Mccrann
Associate Professor
Medical University of South Carolina