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临床试验/CTRI/2019/05/019100
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

Dabur India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:

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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