跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/CTRI/2022/01/039692
CTRI/2022/01/039692尚未招募不适用

To evaluate & compare the in-vivo safety and efficacy of four skin care formulations in terms of reduction of wrinkles on healthy female subjects

MERCK PERFORMANCE MATERIALS PVT LTD1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年1月29日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
To study the safety and efficacy of a skin care formulation in terms of reduction of wrinkles
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Objective: The objective of this study will be to evaluate & compare the in-vivo safety and efficacy of four skin care formulations in terms of reduction of wrinkles on healthy female subjects.

The evaluation is performed using:

  1. Subject Self Evaluation (SSE)

  2. Dermatological Evaluation: Cosmetic Acceptability

  3. Dermatological Evaluation: Efficacy

  4. Chromameter

  5. Cutometer

  6. Corneometer

The study will last 56 days following the first application of the product

Kinetics: Screening , T0, T+28 days 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

  • •Indian Asian 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 Between 35 and 55 years of age.
  • •Skin is healthy on the studied anatomic unit free of eczema, wounds, inflammatory scar Subject having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
  • •using Page number 40 of Skin Ageing Atlas Subject having visible dry skin.

排除标准

  • •Having started, changed or stopped a hormonal treatment in the past 3 months.
  • •Having taken an oral retinoid-based treatment in the past 6 months Having taken a local retinoid-based treatment on the studied areas in the previous month Having had beauty treatment in the previous week Having practiced water activities in the previous week.
  • •Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements Having practiced intensive sports during the day prior to the T0 measurements Having wounds, Scars, sunburns, tattoos and piercing on test site.
  • •Having hair on test site.
  • •Having applied another product than water on the studied areas in the morning of the T0 measurements Having had an intensive UV exposition on the inner forearm prior to T0 measurements Having used cosmetic product on the studied area during 24 hours prior to T0 measurements.

结局指标

主要结局

To study the safety and efficacy of a skin care formulation in terms of reduction of wrinkles

时间窗: T0, T28days, T56days

次要结局

  • To study the efficacy of all the test products in terms of reduction in density of dark spots &(improvement in skin moisturization, skin firmness and skin brightening)

研究者

发起方
MERCK PERFORMANCE MATERIALS PVT LTD
申办方类型
Other [fmcg]

研究点 (1)

Loading locations...

相似试验

尚未招募
不适用
Safety and efficacy assessment of hair care Product on skin
CTRI/2023/07/055079Incnut Lifestyle Retail Pvt Ltd72
尚未招募
不适用
Assessment of safety and effectiveness of product on human volunteers.
CTRI/2025/06/089686Bonji33
尚未招募
Unknown
Safety and efficacy assessment of hair care Product on ski
CTRI/2023/07/055079Incnut Lifestyle Retail Pvt Ltd
尚未招募
Unknown
Assessment of Safety & Efficacy of cosmetic products
CTRI/2023/10/058458EMAMI LTD.
尚未招募
Unknown
Efficacy check of hair care products
CTRI/2023/12/060610SATIYA NUTRACEUTICALS PRIVATE LIMITED