A study to evaluate the Opthalmologic and Dermatologic safety of the Under Eye Serums by Repeat Use Test (7 days) in Healthy Subjects with Equal Representation of Different Skin Types.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the Ophthalmologic and Dermal safety of the test products in causing no ocular irritation or dermal irritation on repeated use of test products involving subjects of varied eye conditions such as normal condition, sensitive condition and contact lens users.To evaluate the product sensorials and post use skin sensorials and efficacy during one week use.
研究概览
简要总结
Study Objective:To evaluate the Ophthalmologic and Dermal safety of the test products incausing no ocular irritation or dermal irritation on repeated use of testproducts involving subjects of varied eye conditions such as normal condition,sensitive condition and contact lens users.To evaluate the product sensorialsand post use skin sensorials and efficacy during one week use.Study Duration: 7 days for each subject. StudyPopulation : 70 male and female subjects with varied eye conditions such asnormal condition, sensitive condition and contact lens users. Age: 25 to 50years. ProductDosage: One drop is to bedispensed on the fingertip and gently massaged over the under eye area andlateral canthus /crows-feet/ outer corners of the eye till it gets absorbedcompletely.Twice daily application during day and night on cleaned under-eyeregion and for 1 week. Assessments:Dermatological Assessment, OphthalmologicAssessment and subject self assessment.
Results: Anti agingserum (AA-43) and Mens under serum (MN-38) caused no ocular irritation at anyof he studied time points. Mean irritation score also indicates that theproduct is non irritant. Anti aging serum (AA-43) caused no dermal irritationat the studied time points. However dermats observed mild shiny appearance ofskin in some subjects. The shiny appearance subsided within a week before thesubjects returned to the next visit. No discomfort was observed. Based onstatistical analysis and subjects feedback it can be concluded with significance thatmore than 95 % of the study participants liked Mens under Eye serum (MN-38) forits color, appearance, spread ability, glossiness, thickness and skin oilyfeel. It also contributed in skin moisturization, softness, smothness andfirmness under the eye region. It helped in reducing under eye dark circleintensity, eye puffiness and youthful appearance. It has helped in to fightwith early signs of aging and reduces finelines and wrinkles. It relaxes, distresses,revives and refreshes the skin. The participants liked overall senosrials.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects in generally good health.
- •2.Subjects willing to abide by the study requirements and protocol.
- •Special criteria: 3.Equal representation of subjects with visible Finelines and / or Wrinkles, Under Eye Puffiness and Under eye dark circles in both groups 4.Atleast 18 Subjects with visible Finelines and / or Wrinkles 5.Atleast 18 Subjects with Under Eye Puffiness 6.Atleast 18 Subjects with Under Eye Dark circles 7.Equal representation of different skin types- Normal, Oily, Dry and Combination Sensitive.
- •8.Subjects of varied eye conditions such as normal condition, sensitive condition and contact lens users.
排除标准
- •1.Women subjects who are pregnant or lactating 2.A known history or present condition of allergic response to any cosmetic products (eye/ facial cosmetic products).
- •3.Subjects having eye infection or allergy.
- •4.Subjects having extremely sensitive eye condition.
- •5.Subjects having any form cutaneous disease which may influence the study result.
结局指标
主要结局
To evaluate the Ophthalmologic and Dermal safety of the test products in causing no ocular irritation or dermal irritation on repeated use of test products involving subjects of varied eye conditions such as normal condition, sensitive condition and contact lens users.To evaluate the product sensorials and post use skin sensorials and efficacy during one week use.
时间窗: Approximately 1 week for each subject
次要结局
未报告次要终点