| CTRI Number |
CTRI/2021/04/033206 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
21/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To check the safety of 3 test product for skin irritation
|
|
Scientific Title of Study
|
Evaluation of Skin Safety of 3 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 |
| CL/133/0321/STU Version No: 1 of 30th March 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Consultant / 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
400057
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Samant |
| Designation |
Chief Scientific Officer |
| Affiliation |
Lyka Labs Limited |
| Address |
Ground Floor, Spencer Building, 30,
Forjett Street, Grant Road (West),
Mumbai
Mumbai
MAHARASHTRA
400036
India |
| Phone |
9870224452 |
| Fax |
|
| Email |
rssamant@lykalabs.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Shweta Daptardar |
| Designation |
Consultant |
| Affiliation |
Lyka Labs Limited |
| Address |
Ground Floor, Spencer Building, 30,
Forjett Street, Grant Road (West),
Mumbai
Mumbai
MAHARASHTRA
400036
India |
| Phone |
9820762974 |
| Fax |
|
| Email |
sadaptardar@lykalabs.com |
|
|
Source of Monetary or Material Support
|
| Lyka Labs Limited
Ground Floor, Spencer Building, 30,
Forjett Street, Grant Road (West),
Mumbai - 400036
Phone: 022-66112200
|
|
|
Primary Sponsor
|
| Name |
Lyka Labs Limited |
| Address |
Ground Floor, Spencer Building, 30, Forjett Street, Grant Road (West), Mumbai - 400036
Phone: 022-66112200 |
| 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 |
Aceclofenac, Menthol, Methyl Salicylate & Linseed Oil Gel (with Acrypol 980) |
0.04 gm of test product will be applied on test site. Then it will be semi-occluded. Duration of occlusion will be 24 hours. |
| Intervention |
Reledol Gel |
0.04 gm of test product will be applied on test site. Then it will be semi-occluded. Duration of occlusion will be 24 hours. |
| Intervention |
Zerodol Gel |
0.04 gm of test product will be applied on test site. Then it will be semi-occluded. Duration of occlusion will be 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 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
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and 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="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)
|
03/05/2021 |
| Date of Study Completion (India) |
04/06/2021 |
| 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)
|
VISIT 1: Patch application
VISIT 2 (24 hrs): Patches was removed.
VISIT 3 (48 hrs): Clinical examination and scoring of test area using Draize scale.
VISIT 4 (1 week): If reactions are observed, participants will be called 1 week thereafter.
The Test Products were found to be "Non Irritant" based on IS 4011:2018, Methods of test for safety evaluation of Cosmetics- Third Revision.
|