CTRI/2023/07/054690尚未招募Unknown
Evaluation of irritation potential of Hair Care formulation on healthy human subjects. - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
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
- •Standard criteria
- •-Asian Indian male and female subjects.
- •-Healthy human subjects (no infectious and evolutive pathology which could make the subject
- •vulnerable and stop the study, no pathology which could interfere with the study, no symptom in
- •the process of an exploratory check-up)
- •-Between 18 and 65 years of age.
- •-Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
排除标准
- •1.Standard criteria
- •-For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •-Having refused to give his/her assent by not signing the consent form.
- •-Taking part in another study liable to interfere with this study.
- •-Being diabetic.
- •-Being asthmatic.
- •-Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •-Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •-Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •-Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •-Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •-The day of the patch application: no cosmetic product must be used (test site clean with water only).
- •2.Refusing to follow the restrictions below during the study:
- •- For female: Do not become pregnant nor breastfeed.
- •- Do not take part in another study liable to interfere with this study. - Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, and antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •- Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
- •3.Specific criteria
- •-Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area.
- •-Having disorder of the healing (whatever the considered area)
- •-Having a rhinitis, allergic conjunctivitis or rhino sinusitis
- •-Having an allergy to perfumes and/or preservatives in cosmetic products.
- •-Having an allergy to plaster
- •-Having a food allergy
- •-Having a cardiovascular pathology (taking a beta blocker treatment)
- •-Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •-Taking a retinoid-based treatment by general or oral route
- •-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 naevus on the back
- •-Having high pilosity on the back.
- •4.Refusing to follow the restrictions below during the study:
- •- During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back.
- •- Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal).
- •- Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches)
- •- Do not expose the back to the sun.
研究者
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