CTRI/2019/05/019100尚未招募未知
To Evaluate Dermatological Safety of Investigational Products In Single Open Application Test on Adult Healthy Human Subjects of All Skin Types
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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 female subjects in the age group of 18-65 years (both age inclusive).
- •2.Subjects with normal, dry, oily, combination and sensitive skin (preferably in equal ratio).
- •3.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire to qualify as sensitive skin.
- •4.Subjects with normal Fitzpatrick skin type III to V.
- •5.Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results.
- •6.Subjects willing to give a voluntary written informed consent.
- •7.Subjects willing to maintain the patch test in position for 24 hours.
- •8.Subject having not participated in a similar investigation in the past two weeks.
- •9.Subjects willing to come for regular follow up visits.
- •Subjects ready to follow instructions during the study period
排除标准
- •1.Infection, allergy on the tested area.
- •2.Skin allergy antecedents or atopic subjects.
- •3.Subjects with known hypersensitivity to any of the study products or constituents.
- •4.Subjects with any significant skin pathology in the investigational area
- •5.Athletes and subjects with history of excessive sweating.
- •6.Cutaneous disease which may influence the study result.
- •7.Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study.
- •8.Subjects on oral corticosteroid.
- •9.Subjects participating in any other cosmetic or therapeutic study.
- •10.Female subjects who are pregnant or lactating.
- •11.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness
研究者
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