| CTRI Number |
CTRI/2021/08/035459 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the safety of 4 test products for skin irritation |
|
Scientific Title of Study
|
Evaluation of skin safety of 4 test products for primary skin irritation using skin irritation test (Patch Test in Humans)
IS 4011:2018 Guidelines.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
C.L.A.I.M.S. Pvt. Ltd.
Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor,
Panam Park, Off Sahar Road, Vile Parle East, Mumbai 400 057,
Tel: 91-22-66758851/52
Mumbai
MAHARASHTRA
400 057
India |
| Phone |
9322276418 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhinav Gupta |
| Designation |
Senior Director – NPD & Operations |
| Affiliation |
Mosaic Wellness Private Limited |
| Address |
Mosaic Wellness Private Limited
(Formerly known as Astrea Body Sciences Pvt. Ltd.)
701, 7th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), Mumbai 400059.
Mumbai
MAHARASHTRA
400059
India |
| Phone |
8879972102 |
| Fax |
|
| Email |
abhinav@mosaicwellness.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhinav Gupta |
| Designation |
Senior Director – NPD & Operations |
| Affiliation |
Mosaic Wellness Private Limited |
| Address |
Mosaic Wellness Private Limited
(Formerly known as Astrea Body Sciences Pvt. Ltd.)
701, 7th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), Mumbai 400059.
MAHARASHTRA
400059
India |
| Phone |
8879972102 |
| Fax |
|
| Email |
abhinav@mosaicwellness.in |
|
|
Source of Monetary or Material Support
|
| Mosaic Wellness Private Limited (Formerly known as Astrea Body Sciences Pvt. Ltd.) 701, 7th
Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), Mumbai 400059 |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Private Limited |
| Address |
Mosaic Wellness Private Limited (Formerly known as Astrea Body Sciences Pvt. Ltd.) 701, 7th
Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), Mumbai 400059 |
| 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 Rajiv Joshi |
C.L.A.I.M.S. PVT. LTD |
Shiv Krupa, S.R.A.
CHS Ltd, C Wing,
Room No: 103, 1st
Floor, Panam Park, Off
Sahar Road, Vile Parle
East, Mumbai 400 057
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9322276418
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indepedent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy skin on test area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline- Negative
Control |
0.04 ml of diluted test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. |
| Intervention |
1% Sodium Lauryl
sulphate-Positive Control |
0.04 ml of diluted test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. |
| Intervention |
Endure Delay Gel |
0.04 ml of diluted test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. |
| Intervention |
Endure Long Last Spray |
0.04 ml of diluted test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. |
| Intervention |
Endure plus Delay Spray |
0.04 ml of diluted test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. |
| Intervention |
Minoxifin Topical Solution |
0.04 ml of diluted test product
will be filled in wells of the patch
chambers. Then it will be
occluded. Duration of occlusion
will be 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Voluntary men and women (preferably equal number of males and females) between 18 and 65 years.
Fitzpatrick skin type III to IV.
Having apparently healthy skin on test area.
|
|
| ExclusionCriteria |
| Details |
Pregnancy (by history) and lactating women.
Scars, excessive terminal hair, or tattoo on the studied area.
Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of cutaneous tolerance by
dermatological scoring of skin reactions using
Draize scale |
48 hours scoring |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2021 |
| Date of Study Completion (India) |
26/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The test products,
· Minoxifin Solution - B.No- WS2141
· Endure Delay Gel - B. No-O21DG001
· Endure Long Last Spray - B. No- EDL21001
· Endure + Delay Spray - B. No-2104042
were dermatologically tested and found to be “Non-Irritant†based on IS 4011 :2018,Methods
of Test for safety evaluation of cosmetics -Third Revision. |