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临床试验/CTRI/2024/04/065604
CTRI/2024/04/065604已完成Unknown

To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers. - NI

ITC LIMITED0 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
Unknown
状态
已完成
发起方
ITC LIMITED
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

  • 1)Female and male Asian Indian subjects.
  • 2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
  • 3)Subjects who have not participated in a similar investigation in the past eight weeks.

排除标准

  • 1)For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.
  • 2) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.
  • 3)Having healing disorder in the concerned area.
  • 4)Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
  • 5) Having an allergy to perfumes and/or preservatives in cosmetic products.
  • 6)Having an allergy to plaster / adhesives used in plaster.
  • 7) Having a food allergy.
  • 8)Having a cardiovascular pathology that requires beta blocking treatments.
  • 9)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
  • 10)Taking a retinoid-based treatment by general or oral route.
  • 11)Taking specific treatment on the back.
  • 12) Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
  • 13)Having miliaria (prickly heat) on the back.
  • 14) Presenting too many neavi on the back.
  • 15) Having high pilosity on the back.

研究者

发起方
ITC LIMITED

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