| CTRI Number |
CTRI/2018/03/012305 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmaceutical] |
| Study Design |
Other |
|
Public Title of Study
|
Testing of safety and effectiveness of Under eye serum and anti aging under eye serum |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/ITUE/2016-03, Version 1.0 dated 22 Apr 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sapna R |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna R |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Ritambhara |
| Designation |
Manager |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
ritambhara@mscr.in |
|
|
Source of Monetary or Material Support
|
| Sponsor:ITC Life Sciences & Technology Centre,
Peenya Industrial area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
| Type of Sponsor |
Other [FMCG (Fast Moving Consumer Goods)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sapna R |
MS Clinical Research Pvt Ltd |
Dermalogical Evaluation room, first floor, 327/15, 1st main road , cambridge layout ulsoor, Bangalore- 560008.
Bangalore
KARNATAKA |
918040917253
918041125934
sapna.r@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
varied eye conditions such as normal condition, sensitive condition and contact lens users |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1) Under eye serum
2) Antiaging under eye serum |
Dose: One drop is to be dispensed on the fingertip and gently massaged over the under eye area and lateral canthus /crows-feet/ outer corners of the eye till it gets absorbed completely.
Frequency:Twice Daily
Route of administration: Topical Application
Duration of therapy: 1 week for each subject |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2016 |
| Date of Study Completion (India) |
30/06/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Objective:
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.Study Duration: 7 days for each subject. Study
Population : 70 male and female subjects with varied eye conditions such as
normal condition, sensitive condition and contact lens users. Age: 25 to 50
years. Product
Dosage: One drop is to be
dispensed on the fingertip and gently massaged over the under eye area and
lateral canthus /crows-feet/ outer corners of the eye till it gets absorbed
completely.Twice daily application during day and night on cleaned under-eye
region and for 1 week. Assessments:Dermatological Assessment, Ophthalmologic
Assessment and subject self assessment.
Results: Anti aging
serum (AA-43) and Mens under serum (MN-38) caused no ocular irritation at any
of he studied time points. Mean irritation score also indicates that the
product is non irritant. Anti aging serum (AA-43) caused no dermal irritation
at the studied time points. However dermats observed mild shiny appearance of
skin in some subjects. The shiny appearance subsided within a week before the
subjects returned to the next visit. No discomfort was observed. Based on
statistical analysis and subjects feedback it can be concluded with significance that
more than 95 % of the study participants liked Mens under Eye serum (MN-38) for
its color, appearance, spread ability, glossiness, thickness and skin oily
feel. It also contributed in skin moisturization, softness, smothness and
firmness under the eye region. It helped in reducing under eye dark circle
intensity, eye puffiness and youthful appearance. It has helped in to fight
with early signs of aging and reduces finelines and wrinkles. It relaxes, distresses,
revives and refreshes the skin. The participants liked overall senosrials. |