CTRI/2024/07/070779尚未招募Unknown
To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with varied skin - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- ITC LIMITED
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.
- •4)Subjects representing varied skin types
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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