Molecular Effects of Topical Calcipotriene on Morphea
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change of Gene Expression From Skin Biopsy
研究概览
简要总结
This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
- •Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
- •Age ≥ 18 years.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
- •Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
- •Subjects may not be receiving any investigational agents.
- •Subjects must not be pregnant or nursing.
- •Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.
研究组 & 干预措施
topical calcipotriene 0.005% ointment
Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects
干预措施: topical calcipotriene 0.005% ointment (Drug)
结局指标
主要结局
Change of Gene Expression From Skin Biopsy
时间窗: day 0 and 3 months
Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels
次要结局
- Quality of Life(day 0 and 3 months)
- Modified Localized Scleroderma Skin Score(day 0 and 3 months)
- Change of Appearance of Skin Biopsy(day 0 and 3 months)
研究者
Lauren Graham
Clinical Instructor in Dermatology
Northwestern University