| CTRI Number |
CTRI/2021/01/030819 [Registered on: 28/01/2021] Trial Registered Prospectively |
| Last Modified On: |
06/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate safety of a test product for skin irritation
|
|
Scientific Title of Study
|
Evaluation of Skin Safety of a test product 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 |
| CL/053/0920/STU Version No: 1 of 8th December 2020 |
Protocol Number |
|
|
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 (Clinical Aesthetics & Investigative Management Service) |
| Address |
B / 4th floor, Modi House, C-10 Dalia Ind. Est., Off New Link Road, Andheri West, Mumbai
Mumbai
MAHARASHTRA
400058
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Abhinav Gupta |
| Designation |
Senior Director – NPD & Operations |
| Affiliation |
Mosaic Wellness Private Limited |
| Address |
701, 7th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), Mumbai
Mumbai
MAHARASHTRA
400059
India |
| Phone |
8879972102 |
| Fax |
|
| Email |
abhinav@mosaicwellness.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhinav Gupta |
| Designation |
Senior Director – NPD & Operations |
| Affiliation |
Mosaic Wellness Private Limited |
| Address |
701, 7th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), Mumbai
Mumbai
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 |
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 |
02266758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT 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 |
Single Patch Application 0.04 ml will be applied on test site and will be occluded for 24 hours. |
| Comparator Agent |
1% Sodium Lauryl sulphate- Positive Control |
Single Patch Application 0.04 ml will be applied on test site and will be occluded for 24 hours. |
| Intervention |
Bodywise Minoxidil Topical Solution USP 5% w/v |
Single Patch Application 0.04 ml will be applied on test site and will be occluded for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Photo type III to V
Having apparently healthy skin on test area
Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study |
|
| 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
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of skin irritation reactions using Draize scale |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
04/03/2021 |
| 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 product, Bodywise (Minoxidil
Topical Solution USP 5% w/v) - B No.: BWF-01 was dermatologically tested and found to be
“Non-Irritant†based on IS 4011:2018, Methods of Test for
safety evaluation of cosmetics - Third Revision.
|