| CTRI Number |
CTRI/2020/07/026455 [Registered on: 09/07/2020] Trial Registered Prospectively |
| Last Modified On: |
08/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of skin care product |
|
Scientific Title of Study
|
Evaluation of irritation potential of Skin Care formulation on healthy human subjects |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q06-KD-JE20, Version No.:01, Dated:12/06/2020 |
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 |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KAMA AYURVEDA PRIVATE LTD |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| Type of Sponsor |
Other [FMCG] |
|
|
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. |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
02243349191
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 |
Regular Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1) Positive Control: Sodium Lauryl Sulphate (SLS) 2) Negative Control: Isotonic Saline Solution |
1)Sodium Lauryl Sulphate (SLS) 1% Solution 2)0.9% Isotonic Saline Solution |
| Intervention |
ORGANIC ALOVERA GEL(ALG2005001) |
The product is a leave on product, so 0.04 ml is placed directly in the aluminum chambers of the patch and applied on the back of the volunteer only once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy Human Subjects
2) is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
3) 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 product |
Baseline,0 hrs,24 hrs and 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Single Application Semi
occlusive, Closed Patch test is conducted to measure the irritation potential
of cosmetic products on the skin
Objective: To evaluate
the irritation potential on healthy human subjects of Skin Care
Formulations.
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. |