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CTRI Number  CTRI/2013/04/003534 [Registered on: 05/04/2013] Trial Registered Retrospectively
Last Modified On: 03/10/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin sensitivity]  
Study Design  Other 
Public Title of Study   24 hours Primary Irritation patch test on healthy human volunteers 
Scientific Title of Study
Modification(s)  		 Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/ITCPT/2013-02 version 1.0 dated 25 feb 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rachana Shilpakar 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore
MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  rachana.shilpakar@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachana Shilpakar 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore
MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  rachana.shilpakar@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Rachana Shilpakar 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore
MS Clinical Research Pvt. Ltd Mezzanine Floor, Classic Court 9/1,Richmond Road, Bangalore
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  rachana.shilpakar@mscr.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ITC R D Centre 
Address  Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India 
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 Rachana Shilpakar  MS Clinical Research Pvt Ltd  Mezzanine Floor, Classic Court,9/1,Richmond road, Bangalore.560025
Bangalore
KARNATAKA 		 918040917253
918041125934
rachana.shilpakar@mscr.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LIFELINE ETHICS COMMITTEE, Bangalore.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skin sensitivity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3% sodium Lauryl sulfate  40 microliter of 3% SLS will be applied on upper back of volunteers using IQ chambers. The patch will be kept for 24 hrs. 
Intervention  Facial Cleanser  40 microliters of each product (undiluted) will be applied on upper back of volunteers using IQ chambers. The patch will be kept for 24 hrs. 
Intervention  Moisturizing Lotion  40 microliters of each product (undiluted) will be applied on upper back of volunteers using IQ chambers. The patch will be kept for 24 hrs. 
Intervention  Skin Cream  40 microliters of each product (undiluted) will be applied on upper back of volunteers using IQ chambers. The patch will be kept for 24 hrs.  
Intervention  Talcum Powder  40 microliters of each product (undiluted) will be applied on upper back of volunteers using IQ chambers. The patch will be kept for approximately 24 hrs. 
Intervention  Talcum Powder  40 microliters of each product (undiluted) will be applied on upper back of volunteers using IQ chambers.the patch will be kept for 24 hrs.  
Intervention  Talcum Powder  40 microliters of each product (undiluted) will be applied on upper back of volunteers using IQ chambers.The patch will be kept for 24 hrs.  
 
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  Approximately 9 Days for each subject.( Total 5 visits) 
 
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)   11/03/2013 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   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  

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 the upper back of  subjects and closed with IQ 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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