CTRI/2022/02/040338已完成未知
Evaluation of dermatological safety of test products by primary irritation patch test on healthy human volunteers of varied skin types
Arbro pharmaceutical Pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy male and female subjects in the age
- •group of 18-55 years(both age inclusive)
- •2. Subject is having valid proof of
- •identity and age
- •3. Subjects with skin phototype III to V
- •4.Subject is having apparently healthy skin on
- •5.Subject representing normal, oily, dry and
- •combination skin type in nearly equal ratio
- •6.Subject willing to give a voluntary written
- •informed consent
- •7.Subject willing to maintain the test patches
- •in designated positions for 24 Hours
- •8.Subject willing to come for regular follow up
- •9.Subject ready to follow instructions during the
- •study period
- •10.Subject without any open wounds, cuts,
- •abrasions, irritation symptoms
排除标准
- •1. Subjects with Known hypersensitivity to any of
- •the study products or constituents
- •2. Subjects having any significant pathology in
- •the test area
- •3. Subjects with any kind of skin allergy,
- •antecedents or cutaneous disease which may
- •influence the study results
- •4. Subjects having topical or systemic treatment
- •in last month prior to participation in the
- •study and during the study that could interfere
- •with the study treatments/ assessments
- •5. Athletes and subjects with history of excessive
- •6. Subject is Pregnant or Lactating
- •7. Subject with any significant medical condition
- •that would interfere with the participation in
- •8. Subjects participated in any other cosmetic or
- •therapeutic trial or in a similar investigation
- •9. Subject is having Scars, excessive terminal
- •hair or tattoo on the studied area
研究者
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Unknown
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