| CTRI Number |
CTRI/2013/12/004191 [Registered on: 05/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/11/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin sensitivity] |
| Study Design |
Other |
|
Public Title of Study
|
Determination of irritation potential of the test products by the predictive patch test techniques |
|
Scientific Title of Study
|
Cumulative Irritancy Study (12 Days) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CIT-02-13Version 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, Richmond Road,
Bangalore
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, Richmond Road,
Bangalore
Bangalore
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, Richmond Road,
Bangalore
Bangalore
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
|
Source of Monetary or Material Support
|
| Study Sponsor: Johnson & Johnson International technical Center Mumbai 400080 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 Center Mumbai-400080 |
| 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
KARNATAKA |
08040917253
08041125934
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 |
Skin Sensitivity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Positive Control-Sodium Lauryl Sulfate (1.0%) |
12 Applications and 12 evaluations daily |
| Intervention |
Product1- Cream, Product2- Hair oil, Product3- Lotion, Product4- Top to toe wash, Product5- Shampoo, Product6- Soap, Product7- Saline (0.9%) |
12 Applications and 12 evaluations daily |
|
|
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 and the use of tanning beds 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.
-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 |
| Determination of Cumulative irritation potential of the test product by predictive patch test technique |
12 days evaluation continuously |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2013 |
| 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="0"
Days="15" |
|
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
|
Study Synopsis:- -The objective of this study is to determine the cumulative irritation potential of the test materials by patch test. -This is a controlled, single center study. Each test material will be applied every day for the 12 days (12 applications). -patches will be applied for approximately a 24 hour period & then graded. -25 normal healthy subjects will be enrolled in the study. Additional 5 subjects will be recruited to compensate for dropouts and incidence of irritation to patch material if any. -The duration of the study is approximately 2 weeks. |