An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Cutaneous Symptom Relief
研究概览
简要总结
The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cutaneous Symptom Relief
时间窗: 2 weeks
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
SkinDex-16 Quality of Life Questionnaire
时间窗: 2 weeks
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
次要结局
未报告次要终点
研究者
Joseph Butterfield
Principal Investigator
Mayo Clinic