CTRI/2013/09/003960已完成2 期
SINGLE APPLICATION CLOSED PATCH TEST TO EVALUATE THE SAFETY OF SKIN CARE FORMULATIONS ON HEALTHY HUMAN SUBJECTS REPRESENTING VARIED SKIN TYPES.
ITC Limited Peenya Industrial Area Peenya Bangalore1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年5月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Volunteer (female/ male) in generally good health.
- •2.Volunteer between the ages of 18 and 50 years.
- •3.Volunteer has not participated in a similar clinical investigation in the past four weeks.
- •4.Volunteer willing to give a written informed consent and come for regular observation.
排除标准
- •1.A known history or present condition of allergic response to any cosmetic products.
- •2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
- •3.Medications (e.g. steroids or antihistamines), which would compromise the study.
- •4.Pregnant or lactating females.
结局指标
主要结局
irritation potential
时间窗: first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal.
次要结局
- investigational products to be tested for irritancy test(On each subject’s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).)
研究者
研究点 (1)
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