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CTRI Number  CTRI/2013/02/003371 [Registered on: 11/02/2013] Trial Registered Retrospectively
Last Modified On: 03/10/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin Sensitivity Test]  
Study Design  Other 
Public Title of Study   Skin sensitivity test to evaluate sensitization of test products. 
Scientific Title of Study
Modification(s)  
Modified Human Repeat Insult Patch Test 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HRIPT -05-12, Version 1.0,dated 2ed Nov 2012  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.
MS Clinical Research Pvt. Ltd. Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore.
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
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, Bangalore.
MS Clinical Research Pvt. Ltd. Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore.
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
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, Bangalore.
MS Clinical Research Pvt. Ltd. Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore.
Bangalore
KARNATAKA
560025
India 
Phone  918040917253  
Fax  918041125934  
Email  mukesh.ramnane@mscr.in  
 
Source of Monetary or Material Support  
Study Sponsor:Johnson & Johnson International Technical Centre Mumbai 400 080. Study Site:MS Clinical Research Pvt Ltd Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore 560025. 
 
Primary Sponsor  
Name  Johnson Johnson 
Address  Johnson & Johnson International Technical Centre Mumbai 400 080 
Type of Sponsor  Other [[FMCG Company]] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMukesh Ramnane  MS Clinical Research Pvt. Ltd.  MS Clinical Research Pvt Ltd Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore 560025.
Bangalore
KARNATAKA 
918040917253
918041125934
mukesh.ramnane@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  Sensitization Potential 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Product1 Cream Product2 Lotion Product3 cream Product4 toner Product5 cleanser Product6 powder Product7 powder Product8 oil   Dose: 20 microlitres will be loaded in the IQ chamber and will be applied on the back of subjects.  
Comparator Agent  Product9 Negative control-Normal Saline. Product10 Positive control-SLS  20 microlitres will be loaded in the IQ chamber and will be applied on the back of subjects. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female subjects 18 to 65 years of age of Indian Race.

Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.

The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.

Willingness to avoid the use of topical products at the test sites during the study.

Willingness to avoid direct sun exposure to the test sites for the duration of the study. 
 
ExclusionCriteria 
Details  Individuals with active or history of psoriasis, active allergic skin responses, or active eczema a
determined by the initial paperwork. Individuals with a history of eczema will be allowed on the study, as long as they complete a supplemental consent.

Individuals with sunburn, acne, abrasions, scar tissue, or tattoos on the test sites, or diseases of the skin that might interfere with the evaluation made in this study or that expose study participants to unacceptable risks.

Women known to be pregnant, nursing, or planning to become pregnant within the next six (6) months
as determined by the initial paperwork.

Use of topical steroids and/or drugs at test sites as determined by the initial paperwork.

Current routine or frequent use of high doses of anti-inflammatory drugs for a defined medical
condition as determined by the initial paperwork. Aspirin use should not exceed two tablets (650 mg)
daily.

Individuals who have had less than a two week rest period since completion of any previous patch
testing.

Individuals with uncontrolled metabolic diseases such as hypertension, hyperthyroidism,
hypothyroidism, diabetes, etc.

Individuals who have had a mastectomy in which axillary nodes were removed as determined by the
initial paperwork.

Individuals currently receiving any anticancer, immunosuppressive treatments/medications, and/or
radiation as determined by the initial paperwork.

Active or untreated skin cancer as determined by the initial paperwork.

Individuals with active hepatitis.

Previous clinically determined allergic reaction on a patch study, or known sensitivities or allergies to personal care products of any type.

Individuals will be admitted to the study at the discretion of the Investigator based on medical history and findings of the pre-study interview and examination. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of sensitization potential of the test products by standard HRIPT method.  6 Weeks and 11 Evaluations for each subject. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2012 
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="1"
Days="15" 
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   Study Synopsis:

Objective of the study is to evaluate the sensitization potential of the test products by modified Human Repeat Insult Patch Test (HRIPT) Method.

Total no. of subjects-110

Total no. of Visits- 14

All the test products will be applied as 48 Hours closed Patch Test on the subjects as 9 repeated applications over the induction phase of 3 weeks.

Evaluation for irritation will be done before application of succeeding patch.

This will be followed by a rest phase of approximately 2 weeks.

Challenge patch of the test products shall be applied at test site and naive site for 48hrs under occlusion , followed by evaluation of sensitization at 48 hrs and 96 hrs post patch application.

The cumulative score of irritation in induction phase will be used to classify the irritation potential of the product.

 
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