CTRI/2023/07/055274尚未招募Unknown
Evaluation of irritation potential of Oral Care formulations on healthy human subjects - NI
Aimil Ayouthveda India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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
- •1. Female and male Asian Indian subjects.
- •2. 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 checkup)
- •3. Between 18 and 65 years of age.
- •4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.
排除标准
- •1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2 Having refused to give his/her assent by not signing the consent form
- •3 Taking part in another study liable to interfere with this study
- •4 Being diabetic.
- •5 Being asthmatic.
- •6 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).
- •7 Having cutaneous hypersensitivity (except in the case of studies
- •with evaluation of sensitive skin).
- •8 Having a diagnosed or highly probable allergy to one or several
- •compounds of the cosmetic products.
- •9 Having undergone a surgery requiring a general anaesthesia of
- •more than one hour in the past 6 months.
- •10 Having changed his/her cosmetic habits in the 14 days preceding
- •the start of the study on the studied anatomic unit.
- •11 The day of the patch application: no cosmetic product must be
- •used (test site clean with water only). 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
- •12 Having eczema, psoriasis, lichen plan, vitiligo whatever the
- •considered area
- •13 Having disorder of the healing (whatever the considered area) •
- •Having a rhinitis, allergic conjunctivitis, or rhino sinusitis
- •14 Having an allergy to perfumes and/or conservatives in cosmetic
- •15 Having an allergy to plaster
- •16 Having a food allergy
- •17 Having a cardiovascular pathology (taking a beta blocker
- •18 Having immunosuppressive drugs, such as cyclophosphamide,
- •methotrexate, azathioprine, etc.
- •19 Taking a retinoid-based treatment by general or oral route
- •20 Taking specific treatment on the back.
- •21 Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
- •22 Having miliaria (prickly heat) on the back.
- •23 Presenting too many naevus on the back
- •24 Having high pilosity on the back.
- •25 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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