| CTRI Number |
CTRI/2021/03/032171 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
29/04/2021 |
| 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 1 test product (Luliconazole & Salicylic Acid & Zinc Pyrithione Shampoo) 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/115/0321/STU Version No: 1 of 1st 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
MAHARASHTRA
400057
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Neeraj Upadhyay |
| Designation |
Quality Assurance Head |
| Affiliation |
Om Sai Pharma Pack |
| Address |
Om Sai Pharma Pack
Plot No. 38 & 39, Sector -11, I.I.E.,
Sidcul, Haridwar (UK)
Hardwar
UTTARANCHAL
249403
India |
| Phone |
7500196600 |
| Fax |
|
| Email |
qa.head@osppgroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Neeraj Upadhyay |
| Designation |
Quality Assurance Head |
| Affiliation |
Om Sai Pharma Pack |
| Address |
Om Sai Pharma Pack
Plot No. 38 & 39, Sector -11, I.I.E.,
Sidcul, Haridwar (UK)
Hardwar
UTTARANCHAL
249403
India |
| Phone |
7500196600 |
| Fax |
|
| Email |
qa.head@osppgroup.com |
|
|
Source of Monetary or Material Support
|
| Om Sai Pharma Pack
Plot No. 38 & 39, Sector -11, I.I.E.,
Sidcul, Haridwar (UK) - 249403. |
|
|
Primary Sponsor
|
| Name |
Om Sai Pharma Pack |
| Address |
Plot No. 38 & 39, Sector -11, I.I.E., Sidcul, Haridwar (UK) - 249403 |
| 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 |
1% Sodium Lauryl sulphate- Positive Control |
Single Patch Application 0.04 ml will be applied and will be occluded for 24 hours. |
| Intervention |
Luliconazole & Salicylic Acid & Zinc Pyrithione Shampoo |
Single Patch Application
0.04 ml of diluted product will be applied and will be occluded for 24 hours. |
| Comparator Agent |
Single Patch Application 0.04 ml of the test product will be applied and was left unoccluded for a specific time. Then, the test site will be occluded. |
Single Patch Application 0.04 ml will be applied and will be occluded for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
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="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2021 |
| Date of Study Completion (India) |
28/04/2021 |
| 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,
• Luliconazole, Salicylic Acid & Zinc
Pyrithione Shampoo - B No.: L20LZ001
was dermatologically tested and found to be
“Non-Irritant†based on IS 4011:2018, Methods of Test for safety evaluation of
cosmetics - Third Revision.
|