NCT01105234已完成1 期
An Irritation Study With New Calcipotriol Ointment Formulations in Healthy 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
- 24
- 试验地点
- 1
- 主要终点
- Clinical scoring of the skin reaction.
研究概览
简要总结
The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects having understood and signed an informed consent form.
- •Either sex
- •Healthy subjects, 18 to 65 years of age
- •Subjects with skin types I to IV according to Fitzpatrick Scale
- •Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.
排除标准
- •Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
- •Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
- •Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
- •Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
- •Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
- •Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
- •Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
- •Known or suspected hypersensitivity to any component of the investigational products
- •Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject
研究组 & 干预措施
Calcipotriol ointment
Experimental
干预措施: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues. (Drug)
结局指标
主要结局
Clinical scoring of the skin reaction.
时间窗: 10 days
Clinical evaluation of the irritation on 8-level scale (from score 0: no evidence of irritation, to score 7: strong reaction speading beyond the application site)
次要结局
- Transepidermal waterloss measurements(10 days)
研究者
研究点 (1)
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