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
|
|
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.
|