CTRI/2024/11/077238已完成不适用
To evaluate the dermatological safety of investigational products through primary irritation patch tests on healthy human volunteers with varied skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ITC LIMITED
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Outcome TimePoints
研究概览
简要总结
Single application, Semi-occlusive and closed occlusive patch study.
Objective: To evaluate the dermatological safety of investigational products through primary irritation patch tests on healthy human volunteers with varied skin.
Duration of study: 9 days [3days and T8 (Evaluation of test sites by Dermatologist and Subject post 1 week of patch removal) visit is scheduled to monitor follow up reactions]
Population 26 healthy subjects(13 males + 13 females)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Female and male Asian Indian subjects.
- •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.
- •Subjects representing varied skin types.
排除标准
- •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.
- •Having eczema, psoriasis, lichen planus, vitiligo etc.
- •in the concerned area.
- •Having healing disorder in the concerned area.
- •Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
- •Having an allergy to perfumes and/or preservatives in cosmetic products.
- •Having an allergy to plaster / adhesives used in plaster.
- •Having a food allergy.
- •Having a cardiovascular pathology that requires beta blocking treatments.
- •Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •Taking specific treatment on the back.
- •Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
- •Having miliaria (prickly heat) on the back.
- •Presenting too many neavi on the back.
- •Having high pilosity on the back.
结局指标
主要结局
Outcome TimePoints
时间窗: Baseline,0 hrs,24 hrs & 7 days
Dermatological safety / Irritation potential on skin
时间窗: Baseline,0 hrs,24 hrs & 7 days
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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