NCT02392130已完成1 期
A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Skin thickness measured by sonography and histology
研究概览
简要总结
The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, 25 to 50 years old inclusive
- •Healthy skin on volar arms with a hairless area sufficient for measurements
排除标准
- •Clinical skin atrophy, telangiectasia or striae on volar arms
- •Presence of any skin condition or colouration that would interfere with test sites or the response or assessment
- •Fitzpatrick skin type IV - VI
- •History or current evidence of infection, eczema or other relevant skin disease
研究组 & 干预措施
Active Drug
Active Comparator
Clobetasol propionate 0.05% ointment
干预措施: Clobetasol propionate 0.05% ointment (Drug)
Experimental Drug
Experimental
LEO 130852A gel 1%
干预措施: LEO 130852A gel 1% (Drug)
Placebo Drug
Placebo Comparator
LEO 130852A placebo gel
干预措施: LEO 130852A placebo gel (Drug)
结局指标
主要结局
Skin thickness measured by sonography and histology
时间窗: 4 weeks
次要结局
- Clinical assessments measured by atrophy score(4 weeks)
- Clinical assessments measured by telangiectasia score(4 weeks)
研究者
研究点 (1)
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