| CTRI Number |
CTRI/2013/01/003306 [Registered on: 21/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin sensitivity] |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate whether the test products causes skin sensitivity / irritation after patch application on human volunteers. |
Scientific Title of Study
Modification(s)
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy volunteers of varied skin types |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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 |
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
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
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 |
Mezzanine Floor, Classic Court,
9/1, Richmond Road
Mezzanine Floor, Classic Court,
9/1, Richmond Road,Bangalore Karnataka.
Bangalore
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@mscr.in |
|
|
Source of Monetary or Material Support
|
| Sponsor - ITC R & D Center
Site - MS Clinical Research Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
ITC RD Center |
| Address |
Peenya Industrial Area,
I Phase, Peenya,
Bangalore- 560058 |
| Type of Sponsor |
Other [FMCG Company] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt Ltd |
Mezzanine floor, Classic Court, 9/1,Richmond Road
Bangalore
KARNATAKA |
918040917253
918041125934
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)
|
40microlitre will be loaded along with other IPs 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 hours. |
| Intervention |
Vivel Deodorant Aerosol Spray (B. No: 60112)
Vivel Deodorant Aerosol Spray (B. No: 60115)
V ivel Deodorant Aerosol Spray (B. No: 60116)
FDW After Shave Balm (B No 17745)
Vivel Ultra Pro Hair Leave On (B.No 18304)
FDW Anti Hair Loss Cream (B.NO: 17709) |
The 40microlitre(undiluted) of each test product will be loaded onto IQ chambers of patch and the same will be pasted on the upper back of volunteers. The patch will be removed after 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects age group 18 - 55 years
• Healthy male & female volunteers
• Subjects with 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 has not participated in a similar investigation in the past two weeks.
• Subjects willing to come for regular follow up.
• Subjects ready to follow instructions during the study period. |
|
| ExclusionCriteria |
| Details |
• Infection, allergy on the tested area
• Skin allergy antecedents or atopic subjects
• Hyper sensitivity to any component of the tested products
• Athletes and subjects with history of excessive sweating
• Cutaneous disease which may influence the study result
• Chronic illness which may influence the cutaneous state.
• Subjects on oral corticosteroid with dose 10mg/day
• Subjects participating in any other cosmetic or therapeutic trial.
• 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 |
0 hour post patch removal, 24 hour and 7 days reading |
|
|
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)
|
08/11/2012 |
| 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="0"
Days="9" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is a dermatologically controlled primary irritation patch test. A
patch test under occlusion is carried out using IQ Chambers with an inside
area of 9X9mm (81mm2).This will be followed by assessment using Draize scale scoring. 24 Healthy human volunteers (Male and Female subjects) will be enrolled into the study. Study duration is 9 days for each subject. Approximately 40 microliters of the test samples will be loaded onto 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. |