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CTRI Number  CTRI/2017/11/010513 [Registered on: 15/11/2017] Trial Registered Retrospectively
Last Modified On: 07/07/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin Sensitivity Patch Test ]  
Study Design  Other 
Public Title of Study   Primary irritation Patch test on healthy human volunteers under occlusion for 24hrs  
Scientific Title of Study   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/ITPT/2015-05, Version 1.0 dated 25 Apr 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRachana Shilpakar 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  MS Clinical Research Pvt. Ltd. 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India
MS Clinical Research Pvt. Ltd. 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India
Bangalore
KARNATAKA
560008
India 
Phone  918040917253  
Fax  918041125934  
Email  rachana.shilpakar@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  DrRachana Shilpakar 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  MS Clinical Research Pvt. Ltd. 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India
MS Clinical Research Pvt. Ltd. 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India

KARNATAKA
560008
India 
Phone  918040917253  
Fax  918041125934  
Email  rachana.shilpakar@mscr.in  
 
Details of Contact Person
Public Query  
Name  DrRachana Shilpakar 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  MS Clinical Research Pvt. Ltd. 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India
MS Clinical Research Pvt. Ltd. 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India

KARNATAKA
560008
India 
Phone  918040917253  
Fax  918041125934  
Email  rachana.shilpakar@mscr.in  
 
Source of Monetary or Material Support  
ITC Life Sciences Technology Centre, Peenya Industrial Area,Ist Phase Peenya Bangalore 560058, Karnataka India. 
 
Primary Sponsor  
Name  ITC Life Sciences Technology Centre  
Address  Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India 
Type of Sponsor  Other [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 Rachana Shilpakar  MS Clinical Research Pvt Ltd  Patch Room, Skin Sensitivity Department, 1st Floor,327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore-560008, Karnataka, India Bangalore
Bangalore
KARNATAKA 		 918040917253
918041125934
rachana.shilpakar@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 
Intervention  1.Soap 2.Soap 3.Soap 4.Soap 5.Soap 6.Soap 7.Soap 8.Soap 9.Deodorant 10.Deodorant.  40 µl of the test products 1-8 (diluted to a concentration 8% w/W in distilled water will be pipetted out on the pre cut filter paper placed inside the allotted IQ ultra chamber prefixed to a micropore tape and 40 µl of the test products 9&10 (deodorant), neat/ without dilution , will be dispensed on the designated site by holdind a surface sterilized stencil on the subjects back ensuring that there is no gap between the stencil and the skin. Product will be allowed to evaporate completely prior to being occluded with a patch. The above products are only for cosmetic testing.The investigational products are topical products comprising ingredients that have been cleared for use and contains approved ingredients as per Indian Standards (IS).  
Comparator Agent  3% Sodium Lauryl Sulphate  Positive control (Sodium Lauryl Sulphate, diluted to a concentration of 3% w/W) will be pipetted out on the pre cut filter paper placed inside the allotted IQ Ultra chamber prefixed to a micropore tape. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  •Subjects in the age group 18 - 55 years (both the ages inclusive).
•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.
•Athletes and subjects with history of excessive sweating.
•Cutaneous disease which may influence the study result.
•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 investigational products on healthy human subjects.  Time points 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)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/05/2015 
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  

Objective:

The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers of varied skin types.

Subject Population:

 24 healthy human volunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).

 Duration of study:

Approximately 9 days for each volunteer

The patch will be applied at the test site of study subjects starting with the lower edge of the patch system and slowly pressing upwards till the top edge in order to squeeze out the air.

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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