CTRI Number |
CTRI/2011/12/002246 [Registered on: 16/12/2011] Trial Registered Retrospectively |
Last Modified On: |
26/12/2012 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Skin sensitisation study] |
Study Design |
Other |
Public Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation 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 |
Trial Acronym |
|
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
Bangalore KARNATAKA 560025 India |
Phone |
80-91-40917253 |
Fax |
80-91-41125934 |
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 |
80-91-40917253 |
Fax |
80-91-41125934 |
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, Bangalore
KARNATAKA 560025 India |
Phone |
80-91-40917253 |
Fax |
80-91-41125934 |
Email |
mukta.sachdev@mscr.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
ITC RD Centre |
Address |
Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
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 Bangalore KARNATAKA |
80-91-40917253 80-91-41125934 mukta.sachdev@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 |
Normal Condition |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
3% Sodium Lauryl Suplhate solution |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
Intervention |
Face Wash – 014-011-B |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
Intervention |
FDW Aqua Vitalize Soap – TSP 55- 146 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
Comparator Agent |
Not Applicable |
Not Applicable |
Intervention |
Speria natural glow soap – TSP 55- 029 A |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
Intervention |
Vivel 3 in 1 facewash +scrub- #3843 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
Intervention |
Vivel GMO Soap – TSP 50-133 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
Intervention |
vivel young Glow Soap –TSP 50-134 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
|
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
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment. |
24HRS, 48HRS, 1 WEEK |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not Applicable |
Not Applicable |
|
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)
|
02/11/2011 |
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
|
Not Apllicable |
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 product/s on skin of healthy human volunteers.
Product/s will be evaluated by carrying out patch test under occlusion for 24 hours.
. Subject Population:
24 healthy human volunteers (Male and Female 1:1)
Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).
Duration of study:
5 visits (9 days for each volunteers)
7. Inclusion / Exclusion Criteria:
7.1 Inclusion Criteria:
� 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.
7.2 Exclusion Criteria:
� 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. |