CTRI/2023/11/059530尚未招募不适用
To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions on healthy female subjects.
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年11月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Ophthalmological safety
研究概览
简要总结
OBJECTIVEThe objective of this study will be to evaluate Ophthalmological safety of test product involving subjects of normal eye conditions on healthy female subjects coded:
Face Cleanser : Product A
The evaluation is performed using:
Subject Self Evaluation (SSE)
Ophthalmological Evaluation: Safety
The study lasts 4 days following the first application of the product.
POPULATION33 female subjects are selected for the study.
The subjects selected for this study are healthy female subjects, aged between 18 to 40 years, having normal eye conditions .
KineticsT0, T+30 minutes after product application, T+1 day, T+3 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian Female subjects.
- •Healthy 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 40 years of age.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5)Subjects having normal eye conditions.
排除标准
- •1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2 Having refused to give her assent by not signing the consent form. 3 Taking part in another study liable to interfere with this study. 4 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months). 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Being epileptic. 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months). 8 Having cutaneous hypersensitivity. 9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10 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). 11 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 13 Having applied a cosmetic product (included make-up) or skin care product on the studied areas the first day of the study (only face cleaned with water is accepted). 14 Refusing to follow the restrictions below during the study:.
- •Do not take part in any family planning activities leading to pregnancy and breastfeeding.
- •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 cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
- •During the study: Do not use other eye related and/ or eye make up than the tested products to the studied areas. (only test cleanser is accepted).
- •The day of the measurements: No test product or any other eye make up must be used (only face cleaned with water is accepted) 15 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, A.H.A….) in the 2 weeks preceding the start of the study. 16 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous 2 weeks. 17 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 1 month 18 Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week. 19 Having permanent make-up on the studied area. 20 Having ocular problems (stye, chalazion, conjunctivitis). 21 Having applied a cosmetic eye product (included eye make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted). 22 Refusing to follow the restrictions below during the study:.
- •Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …).
- •Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …).
- •Do not itch the eyes.
- •Do not wear lenses till the end of the study.
- •Do not use any eye drops or any eye treatment/ surgery during the study.
结局指标
主要结局
Ophthalmological safety
时间窗: Baseline, 30 minutes, Day 1 and Day 3
次要结局
未报告次要终点
研究者
Dr Janaki Y Kodkani
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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