A Phase IV, Randomized, Double Blind, Placebo Controlled, Single-center Study of the Impact of Topical Steroids on Narrow Band UVB (Ultraviolet B) and Dithranol Combination Treatment of Psoriasis (DIPSO)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Relapse 50% PASI after treatment, time to PASI 75% on treatment
研究概览
简要总结
Objective(s):
(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.
(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).
- Trial with medicinal product
详细描述
(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.
(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).
- Trial with medicinal product
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Steroid active treatment
Triamcinolone acetonide 0.1% in unguentum leniens topically
干预措施: Steroid active treatment (Drug)
Vehicle
unguentum leniens topically
干预措施: Steroid active treatment (Drug)
结局指标
主要结局
Relapse 50% PASI after treatment, time to PASI 75% on treatment
时间窗: 2 years
Relapse 50% PASI after treatment, time to PASI 75% on treatment
次要结局
未报告次要终点