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CTRI Number  CTRI/2022/03/040738 [Registered on: 02/03/2022] Trial Registered Prospectively
Last Modified On: 27/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   To study the safety of test products on application in human volunteers 
Scientific Title of Study   Evaluation of Skin Safety of 2 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/156/0222/STU Version No.: 1 of 07 th February 2022  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. 
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
400 057
India 
Phone  02266758851  
Fax    
Email  rsjdrs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kapil Chaudhari 
Designation  Senior Director – R and D 
Affiliation  Mosaic Wellness Private Limited 
Address  701, 7 th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East)

Mumbai
MAHARASHTRA
400059
India 
Phone  9421288153  
Fax    
Email  kapil.chaudhari@mosaicwellness.in  
 
Details of Contact Person
Public Query  
Name  Kapil Chaudhari 
Designation  Senior Director – R and D 
Affiliation  Mosaic Wellness Private Limited 
Address  701, 7 th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East)

Mumbai
MAHARASHTRA
400059
India 
Phone  9421288153  
Fax    
Email  kapil.chaudhari@mosaicwellness.in  
 
Source of Monetary or Material Support  
Mosaic Wellness Pvt. Ltd. 701, 7 th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), 
 
Primary Sponsor  
Name  Mosaic Wellness Private Limited 
Address  701, 7 th Floor, Skyline Icon, Andheri-Kurla Road, Chimatpada, Marol, Andheri (East), 
Type of Sponsor  Other [Health and Wellness] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
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 
Indepedent Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers with healthy skin will be included in the study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Isotonic Saline- Negative Control  Filter papers dipped in Comparator product, (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on back/ upper arm of participants. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
Intervention  Minoxidil 5% Foam  Filter papers dipped in test products, (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on back/ upper arm of participants. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
Intervention  Minoxidil and Finasteride topical solution  Filter papers dipped in test products, (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on back/ upper arm of participants. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
Comparator Agent  Sodium Lauryl sulphate- Positive Control  Filter papers dipped in comparator product, (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on back/ upper arm of participants. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Voluntary men and women (preferably equal number of males and females) between 18
and 65 years.
2. Fitzpatrick skin type III to IV.
3. Having apparently healthy skin on test area.
4. Willingness to discontinue the use of cleansing and/or cosmetic products in the application
areas during the course of the trial
5. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
6. Willing to give written informed consent to participate in the trial after informing all
information concerning the trial procedures and trial objectives.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the trial.
8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna…), during the course of the trial.
9. Should be able to read and write (in English, Hindi, or local language).
10. Ready to wear loose cotton clothes
11. Having valid proof of identity and age.
12. Having not participated in another trial in the past one month. 
 
ExclusionCriteria 
Details  1. Pregnancy (by history) and lactating women.
2. Scars, excessive terminal hair, or tattoo on the studied area.
3. A participant who the Investigator feels will not be compliant with trial requirements
4. Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
6. Any clinically significant systemic or cutaneous disease, which may interfere with trial
procedures.
7. Chronic illness which may influence the outcome of the trial.
8. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the trial (presently or in the past 1 month).
9. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of cutaneous tolerance of skin reactions (erythema, oedema, dryness, scaling, wrinkling), using Draize scale.  48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2022 
Date of Study Completion (India) 02/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None 
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 B. No: MFI21001
• Minoxidil Foam 5% w/w B. No: PAL/MOFF-E/22/001
were dermatologically tested and found to be “Non-Irritant” based on IS 4011 :2018, Methods of Test for safety evaluation of cosmetics -Third Revision.
 
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