| CTRI Number |
CTRI/2021/05/033341 [Registered on: 04/05/2021] Trial Registered Prospectively |
| Last Modified On: |
03/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Not Applicable] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of products on skin |
|
Scientific Title of Study
|
Evaluation of irritation potential of skin care formulations on healthy human subjects |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel,
Mumbai (Suburban)
MAHARASHTRA
400013
India
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel,
Mumbai (Suburban)
MAHARASHTRA
400013
India
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel,
Mumbai (Suburban)
MAHARASHTRA
400013
India
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel,
Mumbai (Suburban)
MAHARASHTRA
400013
India
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel,
Mumbai (Suburban)
MAHARASHTRA
400013
India
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amvigor Organics Pvt Ltd |
| Address |
601-605, 6th Floor, Marathon max,
Junction of Mulund -Goregoan link Rd and LBS Marg,
Mulund (W),
Mumbai – 400080 |
| 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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
MASCOT-SPINCONTROL India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
raji@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 |
Normal Skin Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isotonic Solution: Negative Control SLS: Positive Control |
For Negative Control: 40 μl of 0.9% Isotonic Saline Solution is transferred to previously numbered Aluminium Finn Chamber with an appropriate sized disk of Whatman no. 3 filter paper with the help of Micropipette. For Positive Control: Sodium Lauryl Sulphate solution: 1% w/w solution of SLS in distilled water will be prepared. â€¢ï€ 0.04 ml or 40 μl of the SLS solution will be loaded onto a Whatman filter paper disc, placed in clean Aluminum Finn Chamber. The Finn chamber with the loaded 0.9% Isotonic Saline solution will be taped onto the back of subjects |
| Intervention |
Product A: Clarifying Face Serum (808#); Product B: Face Serum (809#), Product C: Hydrating Face Serum (819#); Product D: AHA & BHA Exfoliating Facial Serum (934#) |
Measure 0.04 ml (40 μl) of test samples with the help of 1 ml syringe/micropipette.
Transfer the test products on previously numbered Aluminium Finn Chamber with an appropriate sized disc of Whatman no. 3 filter paper with the help of syringe/micropipette.
The Finn chambers with the products loaded filter paper discs will then be taped onto the back of subjects. |
|
|
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 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 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)
|
04/05/2021 |
| 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 Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |