| CTRI Number |
CTRI/2012/12/003206 [Registered on: 11/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Skin sensitivity |
| Study Design |
Other |
|
Public Title of Study
|
To understand the skin sensitivity of investigational products by assessing the irritation after patch application on healthy human volunteers |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/KAPT/2012-02,version 1.0,dated 5th Oct 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd, |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore
Bangalore
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd, |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd, |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kao Corporation |
| Address |
2606, Akabane Ichikai-Machi, Haga-gun
Tochigi 321-3497
JAPAN
|
| Type of Sponsor |
Other [Cosmoceutical Industry] |
|
|
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 |
| DrMukta Sachdev |
MS Clinical Research pvt ltd |
Mezzanine Floor,Classic Court,9/1 Richmond Road,
Bangalore
KARNATAKA |
91-80-40917253
91-80-41125934
mukta.sachdev@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 |
Skin sensitivity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3% Sodium Lauryl Sulphate |
Positive Control.
40microliter will be applied in the IQ chambers of patch along with other IPs and the same will be pasted on the upper back of volunteers.The patch will be removed after 24 hrs |
| Intervention |
Brightening Product 1
Brightening Product 2
Brightening Product 3
Brightening Product 4
|
40microliter(undiluted)of each product will be applied in the IQ chambers of patch and the same will be pasted on the upper back of volunteers.The patch will be removed after 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects 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. Infection, allergy on the tested area
2. History of skin allergy antecedents or atopic subjects
3. History of 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
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 product/s on skin of healthy human volunteers by primary irritation patch test |
Assessments will be done at 24 hr,48hr and after 7 days post patch application. |
|
|
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)
|
22/10/2012 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is a primary irritation patch test under dermatological control. A
patch test under occlusion is carried out using IQ Chambers an inside
area of 9X9mm (81mm2) followed by assessment using Draize scale scoring. 24 Healthy human volunteers will be enrolled into the study. Study duration is 9 days for each subject. The required quantity of the sample will be put on 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.
|