Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- erythema score
研究概览
简要总结
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
Study centers A total of 20 subjects will be enrolled in 1 site in France.
Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.
There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.
Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.
The clinical investigation will be conducted in 2 parts.
Part 1 - SPF determination:
To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).
Part 2 - Sun exposure:
To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18-60 years of age,
- •Subject with Phototype I, II or III,
- •Subject with individual typology angle (ITA) 28-70°,
- •Subject with healthy skin / not tanned on the back,
排除标准
- •Subject with obvious skin cancer forms within the test areas,
- •Subject with hairs on the treated area that might interfere with clinical investigation assessments,
- •Subjects who have performed sun bathing at least four months before enrolment,
- •History of sun allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar urticaria, systemic lupus erythematosus, or dermatomyositis).
- •The subject has received, applied or taken the forbidden treatments within the specified time frame prior to the Day 0 visit (list available on request)
结局指标
主要结局
erythema score
时间窗: Part 2 -Day 1
次要结局
未报告次要终点