| CTRI Number |
CTRI/2020/02/023313 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Safety of products on skin |
|
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 |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q39-ZC-JR20; Version:01; Dated: 24/01/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manali Mokadam |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
manali@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manali Mokadam |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
manali@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Banglore, 560058, Karnataka, India |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manali Mokadam |
Mascot Spincontrol India Pvt. Ltd. |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
manali@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Varied Skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Perfume (1042A)
Perfume (1042B)
Perfume (1042C)
Perfume (1042D)
Leave-On (124059)
Leave-On (124054)
Leave-On (126066)
Leave-On (124025)
Leave-On (124044)
Leave-On (124056)
Perfume (7186C)
Perfume (7186G)
Perfume (7186A)
Leave-On (126065)
Rinse-Off (T001)
Rinse-Off (IND 602)
Soap (TSP 123-114)
Soap (TSP 123-115)
Soap (TSP 123-117B)
Soap (TSP 127-184) |
1.For products 1 to 4 the products are aerosol & will be applied by semi occlusive method.
2.For products 5 to 10, the products are leave on product, so are placed directly in the aluminum chambers of the patch and applied on the back of the volunteer.
3.For products 11 to 13 the products are aerosol & will be applied by semi occlusive method.
4.For product 14 the product is leave on product that is placed directly in the aluminum chambers of the patch and applied on the back of the volunteer.
5.For products 15 & 17 to 20 the products are diluted 8% and solution are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit.
6.For product 16
1:5 solution of the investigational product will be prepared by weighing 5g of the product & dissolving it in 25 ml of distilled water. solution is dispensed in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit. |
| Comparator Agent |
Positive Control: Sodium Lauryl Sulphate (SLS);
Negative Control: Isotonic Solution |
Sodium Lauryl Sulphate (SLS) 1% Solution for leave on products
Sodium Lauryl Sulphate (SLS) 3% Solution for Soaps
0.9% Isotonic Saline Solution as negative Control |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 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 |
| Safety assessment of products |
Baseline, 0 hrs, 24 hrs & 7 days |
|
|
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)
|
17/02/2020 |
| Date of Study Completion (India) |
25/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/02/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
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
|
Objective: To evaluate
the irritation potential of investigational products on healthy human subjects .
Duration of study: 8 days study
Kinetics: T0 (Evaluation of
test sites by Dermatologist, Patch application)
T1(Patch
removal, Evaluation of test sites by Dermatologist
T2(Evaluation
of test sites by Dermatologist 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 test area is checked for
erythema and oedema caused due to the products and compared with positive
control. |