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CTRI Number  CTRI/2011/07/001880 [Registered on: 13/07/2011] Trial Registered Retrospectively
Last Modified On: 27/09/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A skin whitening efficacy and safety study in adult, human male subjects 
Scientific Title of Study   A skin whitening efficacy and safety study in adult human male subjects.  
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
BA-PH-1186001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalu Kasliwal 
Designation  Principal Investigator 
Affiliation   
Address  BA Research India Limited Opp. Pushparaj Towers, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  07966135657  
Fax  07966135602  
Email  skasliwal@baresearchindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simran Sethi 
Designation  GM Medical Affairs 
Affiliation   
Address  BA Research India Limited Opp. Pushparaj Towers, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  07966135618  
Fax  07966135641  
Email  ssethi@baresearchindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Sethi 
Designation  GM Medical Affairs 
Affiliation   
Address  BA Research India Limited Opp. Pushparaj Towers, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  07966135618  
Fax  07966135641  
Email  ssethi@baresearchindia.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Ltd Sarkhej-Bavla N. H, No. 8A, Moraiya, Tal:Sanand, 
 
Primary Sponsor  
Name  Cadila Healthcare Ltd 
Address  Sarkhej-Bavla N. H, No. 8A, Moraiya, Tal:Sanand, 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Shalu Kasliwal  BA Research India Limited  Sigma-1 Corporate, Opp. Mann Party Plot, Behind Rajpath Club, Bodakdev Ahmedabad-380054 Gujarat India
Ahmadabad
GUJARAT 		 07966135657
07966135602
skasliwal@baresearchindia.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC -Aditya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skin Whitening Cream  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mens skin whitening cream  Gently apply 1 FTU(Finger Tip Unit) of the product to cleansed face and neck twice a day for 4 weeks. The product will be massaged 5 to 6 times with the help of four finger tips of both hands in circular motions smoothly 
Comparator Agent  Placebo Cream  Gently apply 1 FTU(Finger Tip Unit) of the product to cleansed face and neck twice a day for 4 weeks. The product will be massaged 5 to 6 times with the help of four finger tips of both hands in circular motions smoothly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1)Age: 18-45 years; both inclusive
2)Sex: Male
3)Volunteer is in good physical health as determined by the Investigator/Co-investigator.
4)Volunteer is willing and able to follow the study directions, to participate in the study, returning for all specified visits, and to apply the product only to the part of the areas as per instructions.
5)Volunteers, who are willing to avoid sun bathing, swimming, prolong sun exposure or artificial UV rays during the study.
6)Able to communicate effectively with study personnel.
7)Able to understand and provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1)Volunteers with acne, skin infections over face, widespread active dermatitis or dermatitis on test area.
2)Volunteers with allergies to cosmetics, moisturizers, and whitening/bleaching agents.
3)Volunteer who has sunburned, chapped, or irritated skin or open wounds on test sites.
4)Volunteer who are willing to continue any other personal care products containing whitening/bleaching properties during study period.
5)Volunteer who are swimmers.
6)History or presence of Diabetes.
7)History of skin cancer or treatment for any type of cancer within the last 2 years.
8)Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, acne, eczema, atopic dermatitis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. porphyria).
9)A positive test result for HIV antibody.
10)Participation in a study involving the same test area within the last 30 days.
11)Volunteer who has a condition or is taking or has taken a medication which, in the investigator’s judgment, makes the volunteer ineligible or places the volunteer at undue risk.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Clinical Evaluation using skin fairness score
2. Self Evaluation questionnaire to evaluate the product efficacy and sensorial properties
3. Assessment of skin fairness using Minolta Chromameter  		 1. Baseline visit
2. Week 1
3. Week 2
4. Week 4
 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical evaluation for tolerance and subject compliance to therapy  Week 1, 2, 3 and 4 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2011 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable presently 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A Randomized, Placebo controlled, Investigator/Evaluator blind, Parallel twice daily home use study in healthy adult human male subjects.
The study duration is 4 week application of Men’s Skin whitening cream (Cadila Healthcare Limited, India) and Placebo in 60 subjects.
Primary efficacy measures are (1) Clinical evaluation using skin fairness score (2) Skin fairness assessment using Minolta Chromameter through Lab scale (3) Self evaluation questionnaire to evaluate the product efficacy and sensorial properties.
 
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