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
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
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