| CTRI Number |
CTRI/2018/02/012122 [Registered on: 23/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/02/2018 |
| 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 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/DAPT/2014-04, Version 2.0 dated 9 Jun 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sapna R |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna R |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna R |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited,
Plot No.22, Site IV,
Sahibabad-201010,
Ghaziabad (U.P.),
India.
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot No.22, Site IV,
Sahibabad-201010,
Ghaziabad (U.P.),
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 Sapna r |
MS Clinical Rsearch Pvt Ltd |
327/15, 1st Main Road
Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA |
918040917253
918041125934
sapna.r@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM 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 |
Product1 Oil
Product2 Oil
Product3 Oil
Product4 Cream
Product5 Lotion
Product6 Solution |
The 40 micro liter 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 |
1Subjects in age group 18 - 55 years.
2Healthy male & female subjects.
3.Subjects with Fitzpatrick 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 having not participated in a similar investigation in the past two weeks.
7.Subjects willing to come for regular follow up visits.
8.Subjects ready to follow instructions during the study period.
9.Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same.
|
|
| ExclusionCriteria |
| Details |
•Infection, allergy on the tested area.
•Skin allergy antecedents or atopic subjects.
•Athletes and subjects with history of excessive sweating.
•Cutaneous disease which may influence the study result.
•Subjects on oral corticosteroid >10mg/day.
•Subjects participating in any other cosmetic or therapeutic study.
•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 |
| The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects |
0hr,24hr and 7days 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)
|
25/06/2014 |
| Date of Study Completion (India) |
17/07/2014 |
| 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 investigational products on healthy human subjects. Subject Population: 24 healthy human volunteers. 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 1-8 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 |