Single application closed patch test to evaluate the safety of test formulations on healthy human subjects .
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Irritation potential
研究概览
简要总结
Skin Irritation Test:
Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 14.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- Female
入选标准
- •Is a female in generally good health,Is between the ages of 14 and 18 years,Has not participated in a similar clinical investigation in the past four weeks,Is willing to give a written informed consent and come for regular observation.
排除标准
- •A known history or present condition of allergic response to any cosmetic products,Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,Medications (e.g. steroids or antihistamines), which would compromise the study.
结局指标
主要结局
Irritation potential
时间窗: On each subject’s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs.
次要结局
- Investigational products to be tested for irritancy test(On each subject’s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs)