| CTRI Number |
CTRI/2012/01/002342 [Registered on: 17/01/2012] Trial Registered Prospectively |
| 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 pasting patch on the upper back of 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 |
|
|
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 |
MS Clinical Research Pvt.Ltd.
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 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.
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 |
MS Clinical Research Pvt.Ltd.
Mezzanine floor, Classic court, 9/1 Richmond Road.
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 |
MS Clinical Research Pvt. Ltd
Mezzanine Floor, Classic Court
9/1,Richmond Road, Bangalore 560025, Karnataka, India 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, Bangalore, Dr. Mukta Sachdev |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with skin type III to V, Subjects must not have Infection, allergy on the tested area/Skin allergy antecedents or atopic subjects |
|
|
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. |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
PIPT for New shampoo AD coded 14437 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
| Intervention |
PIPT for New shampoo CDR coded 14439 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
| Intervention |
PIPT for New shampoo TDC coded 14440 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
| Intervention |
PIPT for Vivel Fairness cream coded VTFC#4750 |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
| Intervention |
PIPT for Vivel Moisturising Lotion coded VML-PW |
The product is applied to the upper back of volunteer using IQ chambers in the form of patch. |
| Intervention |
PIPT for Vivel body Lotion coded VBL-PW |
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. |
|
|
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. |
0HRS, 24HRS, 1WEEK ASSESSMENT |
|
|
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)
|
17/01/2012 |
| 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
|
Not Applicable |
|
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. |