CTRI/2022/05/042477已完成未知
The objective of this study will be to evaluate the sensitization potential of Skin Care formulation on healthy human subjects
Transformative Learning Solution Pvt Ltd0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- •1Female and male Asian Indian subjects.
- •2Healthy 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).
- •3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
- •4Photo type III to V.
- •5Having apparently healthy skin on Test area.
- •6For whom the Investigator considers that the compliance will be correct.
- •7Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
- •8Having signed a consent form.
- •9Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •10Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise saunaâ?¦) during the course of the study.
- •11Should be able to read and write in English Hindi or local language.
- •12Having valid proof of identity and age.
排除标准
- •1For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2Having refused to give his/her assent by not signing the consent form
- •3Taking part in another study liable to interfere with this study
- •4Being diabetic.
- •5Being asthmatic.
- •6Following 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).
- •7Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •8Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •9Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •10Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •11The day of the patch application: no cosmetic product must be used (test site clean with water only).
- •12Scars excessive terminal hair or tattoo on the studied area.
- •13Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •14Dermatological infection pathology on the level of studied area.
- •15Hypersensitivity allergy antioxidant to any cosmetic product raw material or hair dye.
- •16Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure.
- •17Chronic illness which may influence the outcome of this study.
- •18Subjects on any medical treatment either systematic or topical which may interfere with the performance of the study treatment presently or in the past one month.
- •19Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial.
- •20Refusing 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). , Do not change his/her cosmetic habit so yeah s apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
- •21Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area
- •22Having disorder of the healing (whatever the considered area)
- •23Having a rhinitis, allergic conjunctivitis, or rhino sinusitis
- •24Having an allergy to perfumes and/or conservatives in cosmetic products
- •25Having an allergy to plaster
- •26Having a food allergy
- •27Having a cardiovascular pathology (taking a beta blocker treatment)
- •28Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •29Taking a retinoid-based treatment by general or oral route
- •30Taking specific treatment on the back
- •31Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
- •32Having miliaria (prickly heat) on the back.
- •33Presenting too many naevus on the back
- •34Having high pilosity on the back
- •35Having scars, excessive terminal hair,
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