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CTRI Number  CTRI/2013/01/003307 [Registered on: 21/01/2013] Trial Registered Retrospectively
Last Modified On: 22/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Primary Irritation patch test on healthy human volunteers.]  
Study Design  Other 
Public Title of Study   To assess the safety of investigational products by assessing the irritation after patch application on human volunteers.  
Scientific Title of Study   Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy volunteers of varied skin types.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/ITCPT/2011-01 Version3.0 dated 15 Nov 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukta Sachdev  
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd,  
Address  Mezzanine Floor, Classic Court,
9/1, Richmond Road, Bangalore Bangalore
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  mukta.sachdev@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukta Sachdev  
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd,  
Address  Mezzanine Floor, Classic Court,
9/1, Richmond Road, Bangalore Bangalore

KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  mukta.sachdev@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Mukta Sachdev  
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd,  
Address  Mezzanine Floor, Classic Court,
9/1, Richmond Road, Bangalore Bangalore

KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  mukta.sachdev@mscr.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  ITC R D Centre 
Address  Peenya Industrial Area, I Phase, Peenya, Bangalore-560085 
Type of Sponsor  Other [FMCG 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
KARNATAKA 		 918040917253
918041125934
mukta.sachdev@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom, Bangalore  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 
Comparator Agent  3% Sodium Lauryl Sulphate  Positive Control. The 40microlitre of will be applied along with other IPs in theIQ chambers of patch and the same will be pasted on the volunteers. The patch will be removed after 24 hours.  
Intervention  Soap(TSP 65-53) Soap(TSP 65-54) Soap(TSP 65-55) Soap(TSP 65-56) Cream-Vivel Active fairness complete fairness cream (VAF-FMS-S). Cream-Vivel Active fairness complete fairness cream (VAF-FMS-S).   All the Products mentioned are used for cosmetic purpose. The 40microlitre of each products will be applied in theIQ chambers of patch and the same will be pasted on the volunteers. The patch will be removed after 24 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Subjects age group 18 - 55 years
Healthy male & female volunteers
Subjects with skin type III to V.
Subjects willing to give a written informed consent.
Subjects willing to maintain the patch test in position for 24 hours
Subject has not participated in a similar investigation in the past two weeks.
Subjects willing to come for regular follow up.
Subjects ready to follow instructions during the study period. 
 
ExclusionCriteria 
Details  Infection, allergy on the tested area
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
Subjects participating in any other cosmetic or therapeutic trial.
Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, 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 
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test.   0hr post patch removal, 24hr post patch removal, and 7 Days post patch removal 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   14/06/2012 
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="0"
Days="7" 
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 primary irritation patch test under dermatological control. A patch test under occlusion is carried out using IQ Chambers  an inside area of 9X9mm (81mm2) followed by assessment using Draize scale scoring.

24 Healthy human volunteers will be enrolled into the study.

Study duration is 9 days for each subject.

The required quantity of the sample will be put on chambers prefixed on tape. 

This patch will then be applied on the test site i.e. between the scapulae and waist of the subjects.  The patch will be kept for 24 hours. After which the patches will be removed and the first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hr and 1 week of patch removal. 

 
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