NCT00719121已完成1 期
Placebo-Controlled, Investigator Blinded, Explorative Trial to Evaluate the Anti-inflammatory Effect of Multiple Topical Applications of R115866 Gel (0.35%) in Two Models of Cutaneous Inflammation in Healthy Male Subjects
Stiefel, a GSK Company1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年11月最近更新:
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
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)
研究概览
简要总结
The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index should be between 18 and 28 kg/m2
- •Subjects are healthy as determined by medical history, physical examination and clinical laboratory tests carried out at screening
- •Subjects with a phototype III or IV (according to Fitzpatrick classification)
排除标准
- •Subjects with history of or active alcohol or substance abuse problems.
- •Known hypersensitivity to azoles, adapalene, retinoids or any other ingredient of the gels
- •Subjects who have a laboratory value which, in the opinion of the investigator, is clinically-relevant out of the normal range
- •Subjects with clinically relevant abnormal ECG-intervals or morphology of the ECG, QTc interval >450 ms
- •Use of vitamin A (>1000 µg/day) or the use of concomitant medication, except paracetamol; All other medication must have been stopped at least 14 days before the first administration of gel)
- •Subjects who have received an investigational product which is not a biological within the month preceding the screening visit; If the investigational product is a biological, a 3-month wash-out period is required.
- •Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
- •Subjects judged by the investigator to have a high probability of lack of compliance with the provisions of the protocol
- •Subjects having any medical condition which, in the opinion of the investigator at the site, is a contraindication to enrollment
研究组 & 干预措施
B
Active Comparator
R115866 (0.35% gel)
干预措施: Talarozole (Drug)
C
Active Comparator
R115866 Vehicle gel
干预措施: Talarozole (Drug)
D
Active Comparator
Differin™, 0.1% adapalene gel
干预措施: Differin™, 0.1% adapalene gel (Drug)
结局指标
主要结局
Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)
时间窗: Day 1 through Day 9 of treatment
次要结局
- Erythema(Day 1 through Day 8 of treatment and Day 15 post-treatment)
研究者
研究点 (1)
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