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临床试验/CTRI/2012/08/002906
CTRI/2012/08/002906已完成未知

Evaluation of the safety of test products for primary skin irritation

Cipla Ltd0 个研究点目标入组 35 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
Cipla Ltd
入组人数
35

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/or women.
  • 2.SLS responders from database or determined by applying SLS patch on volunteers.
  • 3.Between 18 and 65 years.
  • 4.Photo type III and IV.
  • 5.Having apparently healthy skin on test area.
  • 6.Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
  • 7.For whom the investigator considers that the compliance will be correct.
  • 8.Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
  • 9.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
  • 10.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
  • 11.Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study.
  • 12.Ready to wear loose cotton clothes.

排除标准

  • 1.People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking, exercising etc).
  • 2.Pregnant women and lactating women. (as confirmed by UPT)
  • 3.Scars, excessive terminal hair or tattoo on the studied area.
  • 4.Dermatological infection/pathology on the level of studied area.
  • 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
  • 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
  • 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 already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).

研究者

发起方
Cipla Ltd

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