Testing of safety and effectiveness of Under eye serum and anti aging under eye serum

Completed

• Conditions: varied eye conditions such as normal condition, sensitive condition and contact lens users

• Registration Number: CTRI/2018/03/012305
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-13
• Study Completion: 2016-06-30
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Approximately 1 week for each subject

Trial Locations

Locations (1)

MS Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Sapna R

Principal investigator

918040917253

sapna.r@mscr.in