| CTRI Number |
CTRI/2014/01/004295 [Registered on: 07/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
27/08/2015 |
| 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-Repeat insult patch test. |
|
Scientific Title of Study
|
Modified Human Repeat Insult Patch Test |
| Trial Acronym |
HRIPT -01-13 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HRIPT-01-13,version 1.0 dated 29 Aug 2013 |
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
Bangalore
KARNATAKA
560060
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, Bangalore.
MS Clinical Research Pvt. Ltd. Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore.
Bangalore
Bangalore
KARNATAKA
560060
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, Bangalore.
MS Clinical Research Pvt. Ltd. Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore.
Bangalore
Bangalore
KARNATAKA
560060
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Johnson Johnson |
| Address |
Mr. Ram Shukla
Director ,R&D
Johnson & Johnson
International Technical Centre
Mumbai 400 080 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
Mezzanine Floor ,Classic Court 9/1 Richmond Road, Bangalore 560025.
Bangalore
KARNATAKA
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sensitization Potential |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Product 7 Positive control-SLS (1%)
Product 8- Negative control Normal saline |
9 applications in 3 weeks |
| Intervention |
Product1-Cream
Product 2-Hair Oil
Product 3-Lotion
Product 4-Toe wash
Product 5- Shampoo
Product 6-Soap
|
11 applications in 6 weeks |
|
|
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 as 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 form.
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 during the study 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 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 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.
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. |
evaluation on each application visit (14 visits) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIl |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2013 |
| 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="6"
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
Modification(s)
|
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-210
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. |