CTRI/2025/11/096753尚未招募不适用
Evaluation of the sensitization potential of skin care formulation through Dermatological evaluation – Human Repeat Insult Patch Test Method
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Assessment of sensitization potential at Induction phase using the Draize scale and in Challenge phase using the ICDRG scale
研究概览
简要总结
The objective of this study is to evaluate the sensitization potential of a skin care formulation on healthy human subjects.
The evaluation will be performed using the Dermatological Evaluation: Human Repeat Insult Patch Test Method.
Total duration of the study: 40 days following the first application of the product.
Kinetics: The study will include an induction phase with 21 visits (T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19, and T20), followed by a resting phase of 14 days, and a challenge phase of 5 days (T21, T22, T23, T24, and T25).
The study will be conducted in three phases:
- Induction Phase
- Resting Phase
- Challenge Phase
The Induction Phase will last for 21 days, during which 9 repeated applications of patches will be carried out. The patches will be removed after 24 hours of application and will be evaluated after 24 hours of removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor 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.
- •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.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar).
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 not signing the consent form 3)Taking part in another study liable to interfere with this study 4)Being diabetic.
- •Being asthmatic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, 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.
- •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, anti-histamines, 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 13)Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area 14)Having disorder of the healing (whatever the considered area) 15)Having a rhinitis, allergic conjunctivitis or rhino sinusitis 16)Having an allergy to perfumes and/or preservatives in cosmetic products 17)Having an allergy to plaster 18)Having a food allergy 19)Having a cardiovascular pathology (taking a beta blocker treatment) 20)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •Taking a retinoid-based treatment by general or oral route 22)Taking specific treatment on the back 23)Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study 24)Having miliaria (prickly heat) on the back.
- •Presenting too many naevi on the back 26)Having high pilosity on the back 27)Having scars, excessive terminal hair or tattoo on the study area 28)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.
结局指标
主要结局
Assessment of sensitization potential at Induction phase using the Draize scale and in Challenge phase using the ICDRG scale
时间窗: Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40
次要结局
- Adverse events (AEs) and serious adverse events (SAEs)(Day1, Day2, Day 3, Day 4, Day 5, Day 6, Day 7,Day 8, Day 9, Day 10, Day 11, Day 12, Day 13,Day 14,Day 15, Day 16, Day 17,Day 18, Day 19, Day 20, Day 21, Day 36, day 37,Day 38, Day 39, Day 40)
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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