| CTRI Number |
CTRI/2017/05/008635 [Registered on: 23/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity Test] |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the safety of products by skin sensitivity test on human subjects |
|
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/2016-11 Version 1.0 Dated 30 Dec 2016 |
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, First floor, Skin sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
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, First floor, Skin sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
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, First floor, Skin sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences & Technology Centre Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
| Type of Sponsor |
Other [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 |
First floor, Skin sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08040917253
08041125934
rachana.shilpakar@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Product 1 chalk, Product 2 Soap, Product 3 Soap, Product 4 Soap, Product 5 Soap, Product 6 Soap, Product 7 Soap, Product 8 Soap, Product 9 Shower gel, Product 10 Shower gel |
40 microliter of each investigational product with or without dilution (as per the protocol) will be applied back side of the subject.
Dose- 40 Microliter
Frequency- once during the study period
Route of administration- Topical
Duration: 9 days for each ubject |
| Comparator Agent |
SLS (sodium lauryl sulphate) |
40 microliter of 3% sodium lauryl sulfate will be applied back side of the subjects with the test product.
Dose- 40 Microliter
Frequency- once during the study period
Route of administration- Topical
Duration: 9 days for each ubject |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects in age group 18 - 55 years (both the ages inclusive).
2) Healthy male & female subjects.
3) Subjects with Fitzpatrick skin type III to V.
4) Subjects willing to give a voluntary 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. |
|
| ExclusionCriteria |
| Details |
1) Infection, allergy on the tested area.
2)Skin allergy, antecedents or atopic subjects.
3) Athletes and subjects with history of excessive sweating.
4) Cutaneous disease which may influence the study result.
5) Subjects on oral corticosteroid.
6) Subjects participating in any other cosmetic or therapeutic trial.
7) 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 investigational products on healthy human subjects |
Approximately 9 days for each subject |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2017 |
| 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="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
|
Study Objective: The
objective of this study is to evaluate the dermatological safety of the
investigational products on healthy human subjects.
Study 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.
Test Site: Between
the scapula and waist of the subjects, the test site should be free of
pigmentation, pimple, hair, mole or any dermatological condition that can
interfere with the reading.
This patch will then be
applied on the test site. 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 hrs
and 1 week of patch removal. |