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CTRI Number  CTRI/2012/12/003189 [Registered on: 06/12/2012] Trial Registered Retrospectively
Last Modified On: 03/12/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Undereye dark circle and puffiness reduction]  
Study Design  Single Arm Study 
Public Title of Study   To evaluate the efficacy of Men’s Under Eye Serum in reducing the under eye dark circles, puffiness and wrinkles on healthy human male volunteers.  
Scientific Title of Study   Efficacy evaluation of Men’s Under Eye Serum on healthy human male volunteers.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SRC/CD/375, Version: 1.0, Dated: July 20, 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghana Surve 
Designation  Principal Investigator 
Affiliation  The KETs Scientific Research Centre, Cosmetology Division  
Address  The KET’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus,Mithagar Road, Mulund (E), Mumbai- 400 081, India.

Mumbai (Suburban)
MAHARASHTRA
400 081
India 
Phone  25639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Details of Contact Person
Scientific Query  
Name  Meghana Surve 
Designation  Principal Investigator 
Affiliation   
Address  The KET’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus,Mithagar Road, Mulund (E), Mumbai- 400 081, India.


MAHARASHTRA
400 081
India 
Phone  25639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Details of Contact Person
Public Query  
Name  Meghana Surve 
Designation  Principal Investigator 
Affiliation   
Address  The KET’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus,Mithagar Road, Mulund (E), Mumbai- 400 081, India.


MAHARASHTRA
400 081
India 
Phone  25639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Source of Monetary or Material Support  
ITC R&D CENTRE 
 
Primary Sponsor  
Name  ITC RD CENTRE 
Address  Peenya Industrial Area, Peenya, Bangalore - 560058  
Type of Sponsor  Other [Multinational] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aditi Barve  The KET’s, “Scientific Research Centre”, Cosmetology Division,   The Kelkar Education Trust’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus, Mithagar Road, Mulund (E), Mumbai- 400 081, India
Mumbai (Suburban)
MAHARASHTRA 		 25639644

aditi@kelkarcosmetology.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Scientific & Ethics Committee, Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Under eye dark circles, puffiness and wrinkles 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Baseline readings   Baseline (week 0), week 1 to week 8  
Intervention  UES-M  Baseline (week 0), week 1 to week 8 assessment of dermatologist, instrument and subject  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To test the efficacy of investigational formulations in reducing under eye dark circles and puffiness  Baseline (week 0), week 1 to week 8  
 
Secondary Outcome  
Outcome  TimePoints 
To test the efficacy of investigational formulations in reducing under eye fine lines and wrinkles.  Baseline (week 0), week 1 to week 8  
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/10/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   This is a double blind, single center clinical study. There will be only male volunteers in the study. Total 30+ 5 subjects will be enrolled in the study. There will be one investigational product. Subjects will be assigned the investigational product to use on the under eye region twice daily. This will be an 8 weeks study. All the subjects will be assessed on Baseline (week 0), week 1 to week 8.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a double blind, single centered, clinical study. Total 35 (30 + 5 male subjects), healthy human subjects would be enrolled in the study from 25 to 65 years 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, subjects will acclimatize for 15 min after which visual evaluation by 2 Dermatologists and 1 ophthalmologist shall be done, instrumental measurements by Mexameter, Corneometer Visioscan, Digital Imaging of under eye region and Crows feet region, after which product shall be applied by a trained personnel of the site. The above procedure shall be repeated again.

During further visits of week1, week 2, week 3, week 4, week 5, week 6, week 7 and week 8, after 15 min of acclimatization 2 Dermatologists and 1 Ophthalmologist shall do their evaluation, instrumental measurements by Mexameter, Corneometer Visioscan and Digital Imaging of under eye region and Crows feet region and subject self assessment shall be done.

 
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