| CTRI Number |
CTRI/2018/04/013057 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic clinical trail] |
| Study Design |
Other |
|
Public Title of Study
|
to check saftey of investigational products through primary irritation patch test
|
|
Scientific Title of Study
|
Evaluation of of Irritation Potential of Skin Care Formulations. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 01/037/16 version01 26 02 2106 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
MASCOT –SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT –SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL |
| Address |
MASCOT –SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL |
| Address |
MASCOT –SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| MASCOT –SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA |
|
|
Primary Sponsor
|
| Name |
TTK Protective Devices Limited |
| Address |
TTK Protective Devices Limited (Formerly TTK-LIG Ltd)
No.3, Thiruneermalai Main Road| Chrompet|
Chennai – 600 044 | Tamil Nadu | INDIA
|
| Type of Sponsor |
Other [not applicable] |
|
|
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 Siddheshwar Mathpati |
MASCOT-SPINCONTROL India Pvt. Ltd. |
MASCOT –SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA |
022-43349191
siddheshwar@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 |
not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Lubes - Warming (MNWL-026)
2.Lubes -Strawberry (MNFL-016)
3.Lubes - Cherry (MNFL-019)
4.Lubes - Cool- Banana (MNCL-021)
5.Lubes - Cool - Mint (MNCL-024)
|
All the products are leave on products so are 0.04 ml of product placed directly in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) |
3% Solution- 0.04 l directly loaded on aluminium finn chamber and applied to back of subject |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) |
|
| 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, psoriasis, 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
|
T0- baseline
T1-patch removal
T2- dermat grading
T8- follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2016 |
| Date of Study Completion (India) |
18/10/2017 |
| 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)
|
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
|
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 . Duration of study: 8 days study Kinetics: T0 (Patch application), T1(Patch removal), T2(Evaluation of test sites by Dermat post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat post 1 week of patch removal and tracking the positive cases) Population 26 healthy subjects(13 males + 13 females) Products : Lubes- Warming (MNWL-026) , Lubes -Strawberry (MNFL-016) , Lubes - Cherry (MNFL-019) , Lubes - Cool – Banana( MNCL-021) , Lubes - Cool - Mint (MNCL-024) 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
products were non irritant to skin |