| CTRI Number |
CTRI/2018/03/012309 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity Patch Test ] |
| Study Design |
Other |
|
Public Title of Study
|
Testing of Primary Irritation Patch Test under Complete Occlusion for 24hrs 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/2016-01 Version 1.0 Dated 25 Feb 2016 |
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 |
Patch Room, Skin Sensitivity Department, 2nd Floor,327/15, 1st Main Road Cambridge layout, Ulsoor.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Patch Room, Skin Sensitivity Department, 2nd Floor,327/15, 1st Main Road Cambridge layout, Ulsoor.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Patch Room, Skin Sensitivity Department, 2nd Floor,327/15, 1st Main Road Cambridge layout, Ulsoor.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
sapna.r@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 and Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya |
| 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 SapnaR |
MS Clinical Research Pvt Ltd |
Patch Room, Skin Sensitivity Department, 2nd Floor,327/15, 1st Main Road Cambridge layout, Ulsoor.
Bangalore
KARNATAKA |
918040917253
918041125934
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.Deodorant 2.Deodorant 3.Rinse Off 4.Rinse Off 5.Soap 6.Soap 7.Soap 8.Soap 9.Soap 10.Soap |
40 µl of investigational product 1 & 2 (No dilution) will be dispensed on the designated site by holding a clean and surface sterilized stencil on the subject’s back ensuring that there is no gap between the stencil and the skin. Product will be allowed to evaporate completely prior to being occluded with a patch. 40µl of investigational products 3 & 4 (Rinse off product, diluted to a concentration of 8% w/W) will be pipetted out on the pre cut filter paper placed inside the allotted dermaproof aluminium chamber prefixed to a micropore tape.40µl of investigational products 5-10 (soap, diluted to a concentration of 8% w/W) will be pipetted out on the pre cut filter paper placed inside the allotted dermaproof aluminium 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 dermaproof aluminium chamber prefixed to a micropore tape.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects in the 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 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 |
Visit 2 baseline assessments, Visit 3 assessment(after patch removal at 0 hr),Visit 4 assessment (24 hr after patch removal),Visit 5 assessment (day 7 after 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)
|
02/03/2016 |
| Date of Study Completion (India) |
10/03/2016 |
| 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 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 |