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CTRI Number  CTRI/2011/07/001875 [Registered on: 11/07/2011] Trial Registered Retrospectively
Last Modified On: 26/12/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Evaluation of dermatological safety of Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream with a 48 hours closed patch skin sensitization test on healthy human volunteers 
Scientific Title of Study   Evaluation of dermatological safety of Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream with a 48 hours closed patch skin sensitization test on healthy human volunteers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator 
Affiliation  Karnataka Medical Council 
Address  MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic court
9/1, Richmond Road
Bangalore
KARNATAKA
560025
India 
Phone  91-80-40917253  
Fax  91-80-41125934  
Email  mukta.sachdev@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator 
Affiliation  KMC 
Address  MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic court
9/1, Richmond Road

KARNATAKA
560025
India 
Phone  91-80-40917253  
Fax  91-80-41125934  
Email  mukta.sachdev@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator 
Affiliation  KMC 
Address  MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic court
9/1, Richmond Road

KARNATAKA
560025
India 
Phone  91-80-40917253  
Fax  91-80-41125934  
Email  mukta.sachdev@mscr.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sami Labs Ltd 
Address  19/1 & 19/2, I main, II phase, peenya Industrial Area, Bangalore- 560058, Karnataka, India  
Type of Sponsor  Other [Cosmecutical, neutraceutical company] 
 
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 Mukta Sachdev  MS Clinical Research Pvt. Ltd  Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore 560025, Karnataka, India
Bangalore
KARNATAKA 		 80-91-40917253
80-91-41125934
mukta.sachdev@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skin sensitivity test 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  The fairness cream Under eye cream Anti-cellulite cream Age defying cream   1st chamber contains Vaseline as a control. 2nd contains the fairness cream 3rd chamber contains under eye cream 4th chamber contains anti-cellulite cream 5th chamber contains age defying cream 6th chamber contains fairness vehicle/preservative 7th chamber contains under eye cream vehicle/preservative 8th chamber contains anti-cellulite cram vehicle/preservative 9th chamber contains age defying cream vehicle/preservative  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  • Healthy volunteers both male and female
• Subjects ready to sign the informed consent voluntarily and come for regular follow up.
• Subjects of age group 18 - 55 years
• Subjects willing to maintain the applied patch in position for 48 hours
• Subjects who have not participated in a similar investigation in the past four weeks.
• Subjects ready to follow instructions during the study period.
 
 
ExclusionCriteria 
Details  • Infection, allergy on the tested area during screening.
• Skin allergy antecedents or atopic subjects
• Hyper sensitivity to any component of the tested products
• Athletes and subjects with history of excessive sweating
• Cutaneous disease which may influence the study result
• Chronic illness which may influence the cutaneous state.
• Subjects on oral corticosteroid with dose 10mg/day
• Subject in an exclusion period or participating in any other cosmetic or therapeutic trial.
• Any underlying history of uncontrolled medical illness including diabetes mellitus, hypertension, liver disease, HIV, or any other serious medical illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The objective of this study is to evaluate the dermatological safety and potential allergenicity
of Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream on skin of healthy human volunteers.
 		 The outcome will be measured for each volunteer completing 7 days in the study (3 assessment visits- Day 2, Day 4 & Day 7) 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/06/2011 
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="0"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

It is a sensitization clinical study under dermatological control, monocentric, versus control, vehicles and preservatives. A patch test under occlusion is carried out using the aluminium Finn Chambers of 9mm diameter following CODFI (Contact and Occupational Dermatitis Forum of India) guidelines. The allergens used are the negative control (Vaseline), Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream & their vehicles and preservatives. All the antigens are placed at the centre of the Finn chambers and the patch thus prepared is applied on the normal upper back of the healthy subjects for 48 hours.

The patch is removed after 48 hours (day 2) and reading taken after 15 - 20 minutes after removal of patch. The reevaluation for any delayed allergic reaction is done after 96 hours (day 4) and also after one week (day 7) of application.

The irritancy and allergic scoring is done at each visit as per ICDRG scoring for contact dermatitis.

Study would be conducted over a period of 7 days, for each volunteer, which includes a total of 4 visits, at Day 0, 2, 4 and 7.

24 healthy human volunteers between 18 to 55 years of age will be included.

 
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