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CTRI Number  CTRI/2013/02/003369 [Registered on: 11/02/2013] Trial Registered Retrospectively
Last Modified On: 09/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   to access the efficacy of investigational product for it’s salon like tight & bright skin everyday on healthy human female subjects. 
Scientific Title of Study   A double blinded, randomized, comparator, single centered study, to access the efficacy of investigational product for it’s salon like tight & bright skin everyday on healthy human female subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SRC/CD/393, Version: 01, Date: January 10, 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Meghana Surve  
Designation  Principal Investigator  
Affiliation  The KETs Scientific research centre, Cosmetology division  
Address  KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India 
Phone  25639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Meghana Surve  
Designation  Principal Investigator  
Affiliation  The KETs Scientific research centre, Cosmetology division  
Address  KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai

MAHARASHTRA
400081
India 
Phone  25639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Details of Contact Person
Public Query  
Name  Ms Aditi Barve  
Designation  Head Skin Evaluation 
Affiliation  The KETs Scientific research centre, Cosmetology division  
Address  KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India 
Phone  25639644  
Fax    
Email  aditi@kelkarcosmetology.com  
 
Source of Monetary or Material Support  
Hindustan Unilever Limited 
 
Primary Sponsor  
Name  Hindustan Unilever Limited 
Address  Research Centre B D Sawant Marg Chakala Andheri (E) Mumbai- 400 099 Tel: 0120-39830000  
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 
Ms Aditi Barve   The KETs Scientific research centre, Cosmetology division   KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081
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  face brightening & tightening study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.NYIS (serum) 2.NYIC (cream 1)   All the subjects will be dermatologically and self assessed at pre product application (T0) and 15 minutes (T1) and 1 hour (T3) post application of investigational product. Instrumental evaluation will be carried out at pre product application (T0) and 1 hour (T2) & 2 hours (T4) post application of investigational product. As per randomization, either of the products will be allotted to all the subjects. Subjects will be asked to apply allotted investigational product on whole face for single use. 
Comparator Agent  1.SHAC (Cream 2)  All the subjects will be assessed for dermatological evaluation, subject self evaluation and instrumental evaluation on Day 1. All the subjects will be dermatologically and self assessed at pre product application (T0) and 15 minutes (T1) and 1 hour (T3) post application of investigational product. Instrumental evaluation will be carried out at pre product application (T0) and 1 hour (T2) & 2 hours (T4) post application of investigational product. As per randomization, either of the products will be allotted to all the subjects. Subjects will be asked to apply allotted investigational product on whole face for single use. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Volunteer in generally good health.
2.Volunteer between the ages of 25 and 35 years.
3.Volunteer has done salon visits two times in the last one year for cleanup and facial.
4.Volunteer with Fitzpatrick III or IV skin type.
5.Volunteer having visible significant open pores on face.
6.Volunteer has not participated in a similar clinical investigation in the past four weeks
7.Volunteer with no known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.
8.Volunteer not under any dermatologic treatment / prescribed medications.
9.Volunteer willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.
10.Volunteer willing to visit the site at specified frequencies for periodic evaluations.
11.Volunteer willing to comply with study specific requirements.
12.Volunteer willing to give a written informed consent and come for regular observation.
 
 
ExclusionCriteria 
Details  1.A known history or present condition of allergic response to any cosmetic products.
2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
3.On medications (e.g. steroids or antihistamines), which would compromise the study.
4.Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
5.Volunteer; pregnant or nursing.
6.Volunteer viewed by the investigator as not being able to complete the study or participating in another study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to access efficacy of investigational product for it’s salon like tight & bright skin everyday on healthy human female subjects.
 		 All the subjects will be dermatologically and self assessed at pre product application (T0) and 15 minutes (T1) and 1 hour (T3) post application of investigational product. Instrumental evaluation will be carried out at pre product application (T0) and 1 hour (T2) & 2 hours (T4) post application of investigational product. As per randomization, either of the products will be allotted to all the subjects. Subjects will be asked to apply allotted investigational product on whole face. 
 
Secondary Outcome  
Outcome  TimePoints 
The Secondary objective of this study is to access efficacy of investigational product for the Salon like lightening, Softness, Smoothness, Glow, Younger looking skin etc on the healthy human female subjects.   All the subjects will be dermatologically and self assessed at pre product application (T0) and 15 minutes (T1) and 1 hour (T3) post application of investigational product. Instrumental evaluation will be carried out at pre product application (T0) and 1 hour (T2) & 2 hours (T4) post application of investigational product. As per randomization, either of the products will be allotted to all the subjects. Subjects will be asked to apply allotted investigational product on whole face. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/01/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="6" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

People experience change in skin conditions constantly, due to environmental factors, biological factors, psychological state, lifestyle, grooming and other habits etc. Some of these changes are perceived fast and some over a period of time. Maintaining a good appearance not withstanding these changes is a justifiable consumer “want”. In order to fulfill this want and deliver cosmetically appealing appearance to skin, people largely resort to cosmetic treatments.

 One cosmetic intervention that is gaining popularity amongst women is a cosmetic product that would render their skin tight & bright. Cosmetic scientists, world over are constantly searching for solutions to meet the increasing consumer preferences. 

 
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