NCT00812188已完成不适用
A Prospective, Open Label Trial of High Dose UVA-1, 3x/Week or Medium Dose UVA-1, 3x/Week vs. Fluocinonide 0.05% Cream Treatment of Morphea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Efficacy of UVA-1 treatment vs. topical steroid.
研究概览
简要总结
Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 years of age or older.
- •Symmetric limited morphea.
排除标准
- •Known sensitivity to fluocinonide 0.05% cream.
- •Clinical evidence of superinfected skin.
- •Immunocompromised state (including previously documented HIV).
- •Generalized Scleroderma.
- •Previous history of skin cancer.
- •Non-English speaking subjects.
研究组 & 干预措施
Medium Dose UVA-1
Active Comparator
Medium dose (60 J/cm2) UVA-1 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream to another morphea plaque twice daily for twelve weeks.
干预措施: Medium Dose UVA-1 (Other)
High Dose UVA-1
Active Comparator
High dose UVA-1 treatment 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream twice daily for 12 weeks to another morphea plaque.
干预措施: High Dose UVA-1 (Other)
结局指标
主要结局
Efficacy of UVA-1 treatment vs. topical steroid.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Heidi Jacobe
Principal Investigator
University of Texas Southwestern Medical Center
研究点 (2)
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