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临床试验/CTRI/2022/01/039071
CTRI/2022/01/039071已完成未知

Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of apply on healthy human all skin types.

Vasu Research Centre0 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

  • Voluntary men and women ration of 1:1 between 18 and 65 years.
  • Having healthy skin on test area as assessed by dermatological examination.
  • For whom the investigator considers that the compliance will be correct.
  • Subjects with normal, dry, oily and combination skin
  • Subjects cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
  • Having a signed consent form.
  • Subjectsââ?¬• willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study.
  • Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna ââ?¬Â¦.), during the study.
  • Having valid proof of identity and age.
  • Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).

排除标准

  • Pregnant/nursing mothers.
  • Scars, excessive terminal hair, or tattoo on the studied area.
  • Dermatological infection/pathology on level of studied area.
  • Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
  • Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
  • ââ???Chronic illness which may influence the outcome of the study.
  • Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
  • Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.
  • Volunteers evaluated with Fitzpatrick skin type 1,2 and 6 as per the Fitzpatrick scale (Appendix IV).

研究者

发起方
Vasu Research Centre

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