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CTRI Number  CTRI/2018/02/011784 [Registered on: 08/02/2018] Trial Registered Retrospectively
Last Modified On: 07/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Fairness study]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To access the efficacy of test product for it’s salon fair look everyday on healthy human female subjects. 
Scientific Title of Study   Double blinded, randomized, comparator study, to access the efficacy of test product for it’s salon fair look everyday on healthy human female subjects. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
SRC/CD/387, Version :01 , Dated:November 01,2012  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

Mumbai
MAHARASHTRA
400081
India 
Phone  02225639644  
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


MAHARASHTRA
400081
India 
Phone  02225639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Details of Contact Person
Public 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


MAHARASHTRA
400081
India 
Phone  02225639644  
Fax    
Email  meghana@kelkarcosmetology.com  
 
Source of Monetary or Material Support  
Hindustan Unilever Limited  
 
Primary Sponsor  
Name  Hindustan Unilever Limited  
Address  Hindustan Unilever Limited Research Centre, B.D. Sawant Marg,Chakala, Andheri (E), Mumbai- 400 099 Tel: 0120-39830000  
Type of Sponsor  Research institution 
 
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 Meghana Surve  The KET’s, Scientific Research Centre, Cosmetology Division,   The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor, V. G. Vaze College Campus,Mulund (E), Mumbai – 400 081
Mumbai
MAHARASHTRA 		 02225639644

meghana@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  Fairness cream study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FWTS 20 and LPRC 25   Dermatologist assessment on baseline week 1 week 2 & week 4 FWTS 20 Cream 1 appox 0.5gm once in a day and LPRC 25 capsule1 entire capsule in night 
Comparator Agent  TCQW -22 ( Cream 2)-approx 0.5 gm once in a day  Dermatologist assessment on baseline,week 1 ,week 2 & week 4 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1.Subject in generally good health.
2.Subject between the ages of 18 to 30 years.
3.Subject has done salon visits two times in the last one year for cleanup and facial.
4.Subject with Fitzpatrick III & IV skin type.
5.Subject has not participated in a similar clinical investigation in the past four weeks.
6.Subject with no known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.
7.Subject not under any dermatologic treatment / prescribed medications.
8.Subject willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.
9.Subject willing to visit the site at specified frequencies for periodic evaluations.
10.Subject willing to comply with study specific requirements.
11.Subject 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.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.Subject 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   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to ascertain the salon like fairness everyday and associated skin attributes like softness, smoothness, overall appearance, glow, de-tanning, evenness etc on the healthy human female subjects  Baseline, week 1,week 2& week4 
 
Secondary Outcome  
Outcome  TimePoints 
to ascertain the salon like fairness everyday and associated skin attributes like softness, smoothness, overall appearance, glow, de-tanning, evenness etc on the healthy human female subjects  Baseline, week 1,week 2& week4 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "73"
Final Enrollment numbers achieved (India)="73" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/11/2012 
Date of Study Completion (India) 26/12/2012 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
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  

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 notwithstanding 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 fair and moisturized. Cosmetic scientists, world over are constantly searching for solutions to meet the increasing consumer preferences and to ascertain associated skin attributes like softness, smoothness, overall appearance, glow, de-tanning, evenness etc on the healthy human female subjects. 

 
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