CTRI/2025/12/098692尚未招募不适用
Evaluation of the Irritation Potential of Skincare Formulation (Cebhydra Intense) on Sensitive Skin in Healthy Human Subjects through Patch Test Method
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
The objective of this study is to evaluate the irritation potential of a skin care formulation on healthy human subjects with sensitive skin.
Study Population - 26 (13 male & 13 female) healthy subjects with sensitive skin type aged between 18 and 65 years old.
T0 - Baseline & patch application, T1 - 24 hours after patch application - Patch removal, T2 - 24 hours after patch removal - Assessment and scoring, T8 - 1 week after patch removal - follow up.
The skin reaction will be assessed and scored at T2 visit - erythema, dryness, scaliness and wrinkles on a 0-4 point scale and oedema on another 0 - 4 point scale as per Draize Scale.
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 with phototype III-V.
- •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) 3)Between 18 and 65 years of age.
- •Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar) 5)Subjects representing sensitive skin type (as per the Baumann’s questionnaire answered by subjects).
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having eczema, psoriasis, lichen planus, vitiligo at the test site of analysis.
- •Having disorder of the healing at the test site of analysis 4)Having rhinitis, allergic conjunctivitis or rhino sinusitis 5)Having hypersensitivity/ allergy to any cosmetics, perfumes and/or conservatives in cosmetic products, etc.
- •Having an allergy to plaster 7)Having a food allergy 8)Having scar excessive terminal hair or tattoo on studied area 9)Having a cardiovascular pathology (taking a beta blocker treatment) 10)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •Taking a retinoid-based treatment by general or oral route 12)Taking specific treatment on the back.
- •Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study 14)Having miliaria (prickly heat) on the back.
- •Presenting too many naevus on the back 16)Having high pilosity on the back.
- •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 use of water is acceptable 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
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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