NCT02379793已完成1 期
Skin Irritation Test of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
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
- 33
- 试验地点
- 1
- 主要终点
- Skin irritation measured as -, +/-, +, ++, +++, ++++
研究概览
简要总结
The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent has been obtained.
- •Healthy Japanese male subjects.
- •Aged 20 to 40 years inclusive.
- •Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
- •Subjects without a significant abnormality, as judged by the (sub)investigator
排除标准
- •Body Mass Index outside the range 18-25 kg/m²
- •History of alcohol or drug abuse.
- •History of allergic reaction to any medications.
- •Any disease that could in any way confound assessment of the test sites.
- •Known or suspected hypersensitivity to any component of LEO 80185 gel.
- •Known or suspected hepatic, renal or cardiac disorders.
- •Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
- •Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, serological test for syphilis).
- •Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day
- •Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day
- •Use of any medication (systemic or topical) within 2 weeks of Day
- •Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of Day 1, whichever is longest.
- •Current participation in any other interventional clinical trial.
- •Previously enrolled in this clinical trial.
- •Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
- •Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day
- •Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4).
- •In the opinion of the (sub)investigator, participation in the trial is inappropriate.
研究组 & 干预措施
LEO 80185 gel, vehicle, liquid paraffin
Experimental
Each subject has all 3 treatments applied topically at the same time. However, the location on which the treatments are applied is randomised in an investigator blinded manner.
干预措施: LEO 80185 gel, vehicle, liquid paraffin (Drug)
结局指标
主要结局
Skin irritation measured as -, +/-, +, ++, +++, ++++
时间窗: 4 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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