CTRI/2022/05/042920尚未招募不适用
to evaluate in-vivo safety and efficacy of skin care formulationon healthy female subjects
MERCK PERFORMANCE MATERIALS PVT LTD1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年3月6日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Reduction of melasma, Products safety on skin
研究概览
简要总结
OBJECTIVE:The objective of this study will be to evaluate the in-vivo safety and efficacyofskin care formulations on healthy female subjects
**Primary Objective:**To study the safety and efficacy of a skin care formulation in terms ofreduction of melasma.
**Secondary Objective:**To study the efficacy of all the test products in terms of improvement in skinmoisturization, skin firmness and skin brightening & reduction in densityof wrinkles and fine lines.
The evaluation is performedusing:
1 SubjectSelf Evaluation (SSE)
2 DermatologicalEvaluation: Cosmetic Acceptability
3 DermatologicalEvaluation: Efficacy
4 Chromameter
5 Cutometer
6 Corneometer
7 Illustrativephotographs of whole face under diffused ligh
The study will last 56 days following the firstapplication of the product
Kinetics: Screening , T0, T+28days and T+56 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1Indian or Asian female subjects 2Healthy 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 scar) Specific criteria 4Subjects having visible melasma, having crows feet wrinkles of grade 2 and above.
排除标准
- •1Being 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 and Informed consent form 3Taking part in another study liable to interfere with this study 4Being known diabetic case 5Known asthma 6Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7Being known thyroid case 8Being epileptic.
- •9Following a chronic medicinal treatment comprising any of the following products: aspirin based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol) 10Known case of hypersensitivity.
- •11Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
- •14Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
- •16Having taken an oral retinoid-based treatment in the past 6 months 17Having taken a local retinoid-based treatment on the studied areas in the previous month 18Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week 19Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
- •20Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 21Having practiced intensive sports during the day prior to the T0 measurements 22Having wounds, Scars, sunburns, tattoos and piercing on test site.
- •23 Having hair on test site.
- •24Having applied another product than water on the studied areas in the morning of the T0 measurements 25Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
- •26Having used cosmetic product on the studied area during 24 hours prior to T0 measurements.
结局指标
主要结局
Reduction of melasma, Products safety on skin
时间窗: 28 days, 56 days
次要结局
- Improvement in skin moisturization, skin(firmness and skin brightening & reduction in density of wrinkles and fine lines)
研究者
研究点 (1)
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