| CTRI Number |
CTRI/2013/03/003459 [Registered on: 07/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
To know the safety of Investigational products by assessing the irritation after patch application on
healthy human volunteers
|
|
Scientific Title of Study
|
To evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q05-ZC-JR13 (11-02-2013, v01) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Sankpal |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
04, Shah & Nahar Industrial Estate, Off, Dr E. Moses Road, Worli, Mumbai 400018.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
shilpa@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mary Francis |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
04, Shah & Nahar Industrial Estate, Off, Dr E. Moses Road, Worli, Mumbai 400018.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mary@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mary Francis |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
04, Shah & Nahar Industrial Estate, Off, Dr E. Moses Road, Worli, Mumbai 400018.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mary@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC RD CENTRE |
| Address |
ITC R&D CENTRE Peenya Industrial Area, Peenya, Bangalore -
560058. Tel: 080 216303911
|
| Type of Sponsor |
Other [Indian Multinational] |
|
|
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 Mary Francis |
MASCOT-SPINCONTROL India Pvt. Ltd. |
MASCOT-SPINCONTROL India Pvt. Ltd. 04, Shah & Nahar
Industrial Estate, Off, Dr E. Moses Road, Worli ,Mumbai 400018
Maharashtra, India
Mumbai
MAHARASHTRA |
022-43349191
mary@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Independent Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shampoo (17821),
Face Wash (FAPM 61/07),
Face Wash (FAPM 61/16),
Face Wash (TSP 56-194B), Shower Gel( TSP 56-197A) ,
Soap(FG-5064)
|
1. The product is diluted
8% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit 2. The product is diluted 8% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit
3. The product is diluted
8% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit 4. The product is diluted 8% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit
5. The product is diluted
8% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit 6. The product is diluted 8% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit
|
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) 3% Solution |
The SLS is diluted 3% and solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….)
Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination) Subjects willing to come for regular follow up and ready to follow instructions during the study period
|
|
| ExclusionCriteria |
| Details |
For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing
(whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis
|
|
|
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
investigational products by primary irritation
patch test on healthy human volunteers of varied
skin types
|
T0 (before patch application, T1(0 hours after
patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal |
|
|
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)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2013 |
| Date of Study Completion (India) |
28/02/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
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)?
Response - NO
|
|
Brief Summary
|
Single Application Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.
Objective : To evaluate the dermatological safety of investigational products by primary
irritation patch test on healthy human volunteers of varied skin types.
Duration of study: 8 days study
Kinetics: T0 (Evaluation of test sites by Dermat and Subject,
Patch application), T1(Patch removal - 30 minutes acclimatization, Evaluation of test sites by Dermat and Subject post 30 minutes of patch removal), T2(Evaluation of test sites by Dermat and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population 24 healthy subjects(12 males + 12 females) The subjects are selected on the basis of skin types:
3 males + 3 females for dry skin
3 males + 3 females for oily skin
3 males + 3 females for combination skin
3 males + 3 females for normal skin
Products : Shampoo (17821), Face Wash (FAPM 61/07),Face Wash (FAPM 61/16),Face Wash (TSP 56-194B), Shower Gel( TSP 56-197A) ,Soap(FG-5064)
Positive control: 3% SLS
Negative control: Distilled water
The test area is checked for erythema and oedema caused due to the products and
compared with positive control |