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CTRI Number  CTRI/2017/08/009239 [Registered on: 02/08/2017] Trial Registered Retrospectively
Last Modified On: 03/05/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin Sensitivity Test]  
Study Design  Other 
Public Title of Study   24hrs skin sensitivity patch test on healthy human volunteers. 
Scientific Title of Study   Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/DAPT/2013-05,version1.0 dated 06 Jan 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt.Ltd. 
Address  MS Clinical Research Pvt.Ltd. Mezzanine floor, Classic court, 9/1 Richmond Road

Bangalore
KARNATAKA
560025
India 
Phone  08040917253  
Fax  08041125934  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt.Ltd. 
Address  MS Clinical Research Pvt.Ltd. Mezzanine floor, Classic court, 9/1 Richmond Road


KARNATAKA
560025
India 
Phone  08040917253  
Fax  08041125934  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt.Ltd. 
Address  MS Clinical Research Pvt.Ltd. Mezzanine floor, Classic court, 9/1 Richmond Road


KARNATAKA
560025
India 
Phone  08040917253  
Fax  08041125934  
Email  mukesh.ramnane@mscr.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India 
Type of Sponsor  Other [Healthcare and FMCG] 
 
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 Mukesh Ramnane  MS Clinical Research Pvt Ltd  MS Clinical Research Pvt Ltd Dermatology skin sensitivity department Mezzanine Floor, Classic Court 9/1 Richmond Road
Bangalore
KARNATAKA 		 08040917253
08041125934
mukesh.ramnane@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom, Independent Ethics Committee, 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  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  5 product oil, 1 product gel  The 40 micro liter(After dilution for respective products as per EC Approved protocol)of each products will be loaded in IQ chambers and same will be pasted on the upper back of volunteers(between scapula and waist).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 in age group 18 - 55 years
• Healthy male & female subjects
• Subjects with Fitzpatrick 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 having not participated in a similar investigation in the past two weeks.
• Subjects willing to come for regular follow up visits.
• 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
• Subjects participating in any other cosmetic or therapeutic study.
• 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 
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects  0hr,24hr and 7days 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Objective:

The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.

Subject Population:
 24 healthy human volunteers.
 Duration of study:
Approximately 9 days for each volunteer
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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