| CTRI Number |
CTRI/2018/02/012103 [Registered on: 23/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity Test] |
| Study Design |
Other |
|
Public Title of Study
|
24hrs skin sensitivity patch test on healthy human volunteers. |
|
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/2014-01,version 1.0 dated 27-Jan-2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd. |
| Address |
MS Clinical Research Pvt.Ltd.
Mezzanine floor, Classic court, 9/1 Richmond Road,
Bangalore
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd. |
| Address |
MS Clinical Research Pvt.Ltd.
Mezzanine floor, Classic court, 9/1 Richmond Road,
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd. |
| Address |
MS Clinical Research Pvt.Ltd.
Mezzanine floor, Classic court, 9/1 Richmond Road,
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Research and Developement Centre |
| Address |
Peenya Industrial area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India
|
| Type of Sponsor |
Other [FMCG (Fast-moving consumer goods)] |
|
|
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 Rachana Shilpakar |
MS Clinical Research Pvt Ltd |
Mezzanine Floor, Classic Court
9/1,Richmond Road
Bangalore
KARNATAKA |
08040917253
08041125934
rachana.shilpakar@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 |
Skin Sensitivity test |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3% Sodium Lauryl Sulphate |
40 microliter of 3% SLS will be applied on upper back of volunteers using IQ chambers. The patch will be kept for 24 hrs |
| Intervention |
6 products-deodorants,3 products-soaps,1 product-facewash |
The 40 micro liter(After dilution for respective products as per EC Approved protocol)of each products will be loaded in IQ chambers and same will be pasted on the upper back of volunteers(between scapula and waist).The patch will be kept for 24 hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects age group 18 - 55 years
2)Healthy male & female volunteers
3)Subjects with skin type III to V.
4)Subjects willing to give a written informed consent.
5)Subjects willing to maintain the patch test in position for 24 hours
6)Subject has not participated in a similar investigation in the past two weeks.
7)Subjects willing to come for regular follow up.
8)Subjects ready to follow instructions during the study period. |
|
| ExclusionCriteria |
| Details |
1)Infection, allergy on the tested area
2)Skin allergy antecedents or atopic subjects
3)Hyper sensitivity to any component of the tested products
4)Athletes and subjects with history of excessive sweating
5)Cutaneous disease which may influence the study result
6)Chronic illness which may influence the cutaneous state.
7)Subjects on oral corticosteroid with dose >10mg/day
8)Subjects participating in any other cosmetic or therapeutic trial.
9)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 given investigational products on healthy human volunteers of varied skin types. |
evaluations done at 0hr,24hr and 7 days 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)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2014 |
| Date of Study Completion (India) |
22/02/2014 |
| 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
|
None Yet. |
|
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 required quantity of the sample will be put on the upper back of subjects and closed with IQ chambers prefixed on tape.
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. RESULTS:Investigational products 1-10 emerged as non irritant products when observed at 0hr, 24 hrs and 7 days post patch removal. Positive control was confirmed as irritant when observed at 0hr and 24 hrs post patch removal and was non irritant when observed at day 7 post patch removal. The assessment was done as per Draize scale for scoring irritation mentioned in Clause 4.3.1.3 in IS 4011:1997 Methods of test for safety evaluation of cosmetics, reaffirmed (2004), Edition 3.2 (2007-11), second revision (ICS 71.100.40), clause 4.3.1,4.3.1.2 BIS 2008 at 0hr, 24hrs and day7 post patch removal readings |