NCT00958516已完成1 期
A Phase 1 Study Evaluating the Phototoxic Potential of LEO 29102 Cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g) and the Cream Vehicle, Applied on Intact Skin of Healthy Male 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
- 32
- 试验地点
- 1
- 主要终点
- Phototoxic reaction according to the investigator's assessment
研究概览
简要总结
The purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of LEO 29102 cream in different doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects having understood and signed an informed consent form
- •Male adults between the age of 18 and 65 years (both inclusive)
- •Healthy subjects without signs of skin irritation on test areas (erythema, dryness, roughness or scaling)
- •Subjects willing and able to follow all the study procedures and complete the whole study
- •Subjects affiliated to a social security system
排除标准
- •Males who are not willing to use a local contraception for the entire duration of the study, and refrain from fathering a child within 3 months following the study drug
- •Systemic treatments which may interfere with the inflammatory reaction (e.g., corticosteroids and other anti-inflammatory drugs) within 2 weeks prior to randomisation
- •Systemic or topical treatments suspected of causing photobiological reactions (e.g., tetracycline, thiazides, fluoroquinolones) within 4 weeks prior to randomisation
- •Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 4 weeks prior to inclusion or is planned during the study period
- •Dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin types V and VI on the Fitzpatrick scale)
- •Scars, moles, sunburn or other blemishes in the test area which may interfere with grading
- •Any systemic or cutaneous disease on the test area that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
- •Relevant history of or concurrent photo-induced or photo-aggravated disease (abnormal response to sunlight
- •Subjects with a history of serious allergy, allergic skin rash or known sensitivity to any component of the investigational products
- •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 the last four (4) weeks before randomisation
- •Participation in any other current interventional clinical trial based on interview of the subject
- •Previously randomised in this trial
- •Subjects impossible to contact in case of emergency
- •Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
- •Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health
- •Subjects under guardianship, hospitalised in a public or private institution for a reason other than research or subject deprived of freedom
研究组 & 干预措施
LEO 29102 cream
Experimental
干预措施: LEO 29102 cream (Drug)
结局指标
主要结局
Phototoxic reaction according to the investigator's assessment
时间窗: 5 days
次要结局
- Clinical scoring and other skin reactions(5 days)
研究者
研究点 (1)
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