Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Photosensitization as measured through the use of dressings containing tested product and placebo
研究概览
简要总结
The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
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
- •Age between 18 to 60 years old;
- •Skin types: I (light caucasian) or III (light brown);
- •Intact skin where the product will be applied;
- •Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
- •Signature of informed consent form
排除标准
- •Pregnancy and lactation
- •Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
- •Diseases that cause immune suppression;
- •Use of photosensitizing drugs;
- •History or photodermatoses activities;
- •Personal or family history of photoinduced skin cancer;
- •Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
- •Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;
- •Previous participation in a study with the same product under test;
- •Relevant medical history or current evidence of alcohol or other drugs abuse;
- •Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
- •Sponsor's employees involved in the study, or close family member of an employee involved in the study;
结局指标
主要结局
Photosensitization as measured through the use of dressings containing tested product and placebo
时间窗: 32 days
The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and irradiated with UVA. That procedure occurs during the period of 32 days.
Photoirritation as measured through the use of dressings containing tested product and placebo
时间窗: 05 days
The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and irradiated with UVA. That procedure occurs during the period of five days.
次要结局
未报告次要终点