| CTRI Number |
CTRI/2021/04/033255 [Registered on: 29/04/2021] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To check the safety of 1 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/132/0321/STU Version No: 1 of 26th March 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Dermatologist / Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT. LTD (Clinical Aesthetics & Investigative Management Service) |
| Address |
Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor,
Panam Park, Off Sahar Road, Vile Parle East, Mumbai
Mumbai
MAHARASHTRA
400 057
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BVK Rao |
| Designation |
Vice President - R&D |
| Affiliation |
Apex Laboratories Pvt. Ltd. |
| Address |
Apex Laboratories Pvt. Ltd.
R&D Centre
B-59, SIPCOT Industrial Estate
Irungattukottai, Sriperumbudur (TK)
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
044-67117770 |
| Fax |
|
| Email |
bvkrao@apexlab.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSVelmurugan |
| Designation |
Scientist-II - R&D |
| Affiliation |
Apex Laboratories Pvt. Ltd. |
| Address |
Apex Laboratories Pvt. Ltd.
R&D Centre
B-59, SIPCOT Industrial Estate
Irungattukottai, Sriperumbudur (TK)
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
044-67117720 |
| Fax |
|
| Email |
velmurugan-rnd@apexlab.com |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Pvt. Ltd.
R&D Centre
B-59, SIPCOT Industrial Estate
Irungattukottai, Sriperumbudur (TK)
Kancheepuram Dist - 602105.
Phone: 044-67117770 / 67117720 |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
R&D Centre B-59, SIPCOT Industrial Estate Irungattukottai, Sriperumbudur (TK) Kancheepuram Dist - 602105. Phone: 044-67117770 / 67117720 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
0.04 ml of negative control will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours.
|
| Comparator Agent |
1% Sodium Lauryl sulphate-Positive Control |
0.04 ml of positive control will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours.
|
| Intervention |
Mincipex (Minoxidil Topical Solution USP 5% w/v) |
0.04 ml of 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 |
Fitzpatrick skin type III to IV.
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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of cutaneous tolerance by dermatological scoring of skin reactions using Draize scale |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2021 |
| Date of Study Completion (India) |
14/06/2021 |
| 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, Mincipex (Minoxidil Topical
Solution USP 5% w/v) - B No.: 101DS101 was dermatologically tested and found to
be “Non-Irritant†based on IS 4011:2018, Methods of Test for safety evaluation
of cosmetics - Third Revision. |