| CTRI Number |
CTRI/2016/07/007064 [Registered on: 05/07/2016] Trial Registered Retrospectively |
| Last Modified On: |
04/07/2016 |
| 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/2015-10, Version 1.0 dated 13 Nov 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt,Ltd |
| Address |
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
Bangalore
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt,Ltd |
| Address |
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
Bangalore
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt,Ltd |
| Address |
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
Bangalore
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08041125934 |
| Email |
sapna.r@mscr.in |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Centre |
|
|
Primary Sponsor
|
| Name |
ITC Life Science and Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
| 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 |
| DrSapnaR |
MS Clinical research Pvt.Ltd. |
MS Clinical Research Pvt. Ltd First floor, skin sensitivity room,327/15, 1st Main Road Cambridge layout, Ulsoor KARNATAKA 560008 Bangalore
KARNATAKA
560008
India
Bangalore
KARNATAKA |
08041125934
08041125934
sapna.r@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 |
Sensitive skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Soap 2.Soap 3.Soap 4.Soap 5.Soap 6.Soap 7.Soap 8.Soap 9.Soap 10.Soap 11.Soap 12.Skin Leave on 13.Skin Leave on 14.Skin Leave on |
40 µl of the investigational products 1-11 (Soap diluted to a concentration 8% w/W) will be pipetted out on the pre cut filter paper placed inside the allotted IQ ultra chamber prefixed to a micropore tape.40 µl of the investigational products 12-14 (skin leave on,neat/without dilution) will be placed directly inside the allotted IQ Ultra chamber prefixed to a micropore tape.The above products are only for cosmetic testing.The investigational products are topical products comprising ingredients that have been cleared for use and contains approved ingredients as per Indian Standards (IS). |
| Comparator Agent |
3% Sodium Lauryl Sulphate |
Positive control (Sodium Lauryl Sulphate, diluted to a concentration of 3% w/W) will be pipetted out on the pre cut filter paper placed inside the allotted IQ Ultra chamber prefixed to a micropore tape |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects in the age group 18 - 55 years (both the ages inclusive).
•Healthy male & female subjects.
•Subjects with Fitzpatrick skin type III to V.
•Subjects willing to give a written informed consent.
•Subjects willing to maintain the patch test in position for 24 hours.
•Subject having not participated in a similar investigation in the past two weeks.
•Subjects willing to come for regular follow up visits.
•Subjects ready to follow instructions during the study period. |
|
| 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.
•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 |
| 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)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2015 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective: The Objective of the study is to evaluate the dermatological safety of investigational products on healthy human subjects
Subject Population: 24 healthy human volunteers (Male and Female 1:1) with skin type 1:1:1:1 ratio ( Oily,Dry,Normal and Combination)
Duration of study: Approximately 9 days for each volunteer The patch will be applied at the test site of study subjects starting with the lower edge of the patch system and slowly pressing upwards till the top edge in order to squeeze out the air.
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 |