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临床试验/CTRI/2023/05/053321
CTRI/2023/05/053321进行中(未招募)4 期

Evaluation of Skin Safety of test product using 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Participants with Non-Sensitive Skin

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
4 期
状态
进行中(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.Voluntary men and women ratio of 1:1 between 18 and 65 year
  • 2.Having healthy skin on test area as assessed by
  • dermatological examination
  • 3.For whom the investigator considers that the compliance will be correct
  • 4. Subjects with normal, dry, oily and combination skin in approximately equal ratio.
  • 5. Subjects cooperating informed of the need and duration of the examination and ready to comply
  • with protocol procedures.
  • 6. Having a signed consent form.
  • 7. Subjects’ willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study.
  • 8. Willingness to avoid excessive water contact (for example swimming) or activity which causes
  • excessive sweating (that is exercise, sauna ….), during the study.
  • 9. Having valid proof of identity and age.
  • 10. Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).

排除标准

  • 1.Pregnant/nursing mothers.
  • 2.Scars, excessive terminal hair, or tattoo on the studied area.
  • 3.Dermatological infection/pathology on level of studied area.
  • 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
  • 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
  • 6.Chronic illness which may influence the outcome of the study.
  • 7.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).
  • 8.Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.

研究者

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