Efficacy evaluation of Men’s Under Eye Serum on healthy human male volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To test the efficacy of investigational formulations in reducing under eye dark circles and puffiness
研究概览
简要总结
Thisis a double blind, single centered, clinical study. Total 35 (30 + 5 malesubjects), healthy human subjects would be enrolled in the study from 25 to 65years age group. Subjects visit the site on week 0, week 1, week 2, week 3,week 4, week 5, week 6, week 7 and week 8. During the week 0 visit, subjectswill acclimatize for 15 min after which visual evaluation by 2 Dermatologistsand 1 ophthalmologist shall be done, instrumental measurements by Mexameter,Corneometer Visioscan, Digital Imaging of under eye region and Crows feetregion, after which product shall be applied by a trained personnel of thesite. The above procedure shall be repeated again.
Duringfurther visits of week1, week 2, week 3, week 4, week 5, week 6, week 7 andweek 8, after 15 min of acclimatization 2 Dermatologists and 1 Ophthalmologist shall do theirevaluation, instrumental measurements by Mexameter, Corneometer Visioscan and DigitalImaging of under eye region and Crows feet region and subject self assessmentshall be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects in generally good health.
- •2.Subjects in the age group of 25 to 65 years.
- •3.17-18 subjects with moderate to severe under eye dark circles, 17-18 Subjects with puffiness, 17-18 Subjects with moderate to severe fine lines and wrinkles in addition to either of the above mentioned conditions.
- •4.Subjects free of any obvious infection of skin as determined by dermatologist.
- •5.Subject has not participated in a similar investigation in the past four weeks.
- •6.Subjects have not used a similar product for the last four weeks.
- •7.Subjects willing to give a written informed consent and come for regular follow up.
排除标准
- •1.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, hydroquinone, vitamin C, Niacin amide, retinol, soy etc.
- •2.Currently or has been using a similar type of product within the last 1 month.
- •3.Currently or has been undergoing dermatologist skin treatments or procedures within the last 1 month.
- •4.Currently or has been involved in another skin care clinical investigation within the last 1 months.
- •5.Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator.
- •6.Subjects viewed by the investigator as not being able to complete the study.
结局指标
主要结局
To test the efficacy of investigational formulations in reducing under eye dark circles and puffiness
时间窗: Baseline (week 0), week 1 to week 8
次要结局
- To test the efficacy of investigational formulations in reducing under eye fine lines and wrinkles.(Baseline (week 0), week 1 to week 8)