CTRI/2023/09/057658尚未招募Unknown
The objective of this study will be to evaluate the sensitization potential of Skin Care formulations on healthy human subjects. - Nil
Transformative Learning Solution Pvt Ltd0 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
- •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 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •4 Photo type III to V.
- •5 Having apparently healthy skin on Test area.
- •6 For whom the Investigator considers that the compliance will be correct.
- •7 Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
- •8 Having signed a consent form.
- •9 Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •10 Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise sauna…) during the course of the study.
- •11 Should be able to read and write in English Hindi or local language.
- •12 Having valid proof of identity and age.
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).
- •12 Scars excessive terminal hair or tattoo on the studied area.
- •13 Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •14 Dermatological infection pathology on the level of studied area.
- •15 Hypersensitivity allergy antioxidant to any cosmetic product raw material or hair dye.
- •16 Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure.
- •17 Chronic illness which may influence the outcome of this study.
- •18 Subjects 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.
- •19 Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial.
- •20 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, 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
研究者
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