| CTRI Number |
CTRI/2018/02/011971 [Registered on: 19/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity] |
| Study Design |
Other |
|
Public Title of Study
|
24hrs skin sensitivity occlusive 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/2014-06, Version 1.0 dated 09 May 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 |
327/15, 1st Main Road,
Cambridge layout,
Ulsoor, Bangalore-560008,
Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| 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 |
327/15, 1st Main Road,
Cambridge layout,
Ulsoor, Bangalore-560008,
Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| 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 |
327/15, 1st Main Road,
Cambridge layout,
Ulsoor, Bangalore-560008,
Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| 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 [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 Rachana Shilpakar |
MS Clinical Research Pvt Ltd. |
327/15, 1st Main Road,
Cambridge layout,
Ulsoor, Bangalore 560008,
Karnataka, India.
Bangalore
KARNATAKA |
918040917253
08041125934
rachana.shilpakar@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
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 |
| Intervention |
1)Soap
2)Soap
3)Soap
4)Wet wipes
5)Cleansing solution
6)Cleansing solution
7)Wet wipes
8)Wet wipes
|
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.
Dose: 40 micro liters.
Duration: Approximately 9 days for each subject. |
| 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
Dose: 40 Micro liter
Duration: Approximately 9 days for each subject. |
|
|
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.
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.nfection, 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. |
0hrs,24 hrs and 7 days post patch removal reading |
|
|
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)
|
14/05/2014 |
| Date of Study Completion (India) |
23/05/2014 |
| 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 1-8 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 |