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CTRI Number  CTRI/2021/03/032121 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 07/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin Sensitivity test]  
Study Design  Other 
Public Title of Study   To evaluate the safety of test products 
Scientific Title of Study   Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
SAFE/ITPT/2021-01 Version 1.0 Dated 26 Feb 2021   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd  
Address  Ground floor, Sensitivity room, 327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934   
Fax  08040917253  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd  
Address  Ground floor, Sensitivity room, 327/15, 1st Main Road Cambridge layout, Ulsoor


KARNATAKA
560008
India 
Phone  08041125934   
Fax  08040917253  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd  
Address  Ground floor, Sensitivity room, 327/15, 1st Main Road Cambridge layout, Ulsoor


KARNATAKA
560008
India 
Phone  08041125934   
Fax  08040917253  
Email  mukesh.ramnane@mscr.in  
 
Source of Monetary or Material Support  
ITC Life Sciences & Technology Centre, Peenya Industrial Area, I Phase, Peenya,Bangalore- 560058, Karnataka, India.  
 
Primary Sponsor  
Name  ITC Life Sciences Technology Centre  
Address  Peenya Industrial Area, I Phase, Peenya  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukesh Ramnane  MS Clinical Research Pvt. Ltd.  Ground floor, Sensitivity room No. 1 ,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
mukesh.ramnane@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male and Female subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Perfume Spray   40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject  
Intervention  10.Surface Cleaner  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Comparator Agent  11.Negative control(0.9N Saline)  40 microliter of Negative control (0.9N Saline) will be applied on the back side of the subject along with the test products. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Comparator Agent  12.Positive control(1% SLS)  40 microliter of Positive control (1% SLS) will be applied on the back side of the subject along with the test products. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  2.Perfume Spray  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  3.Perfume Spray  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  4.Perfume Spray  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  5.Perfume Spray   40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  6.Deodorant  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  7.Deodorant  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  8.Deodorant   40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
Intervention  9.Deodorant  40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter Frequency- once during the study period Route of administration- Topical Duration: 9 days for each subject 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects in age group 18 - 65 years (both the ages inclusive).
2.Healthy male & female subjects.
3.Subjects with Fitzpatrick skin type III to V.
4.Subjects willing to give a voluntary written informed consent.
5.Subjects willing to maintain the patch test in position for 24 hours.
6.Subject having not participated in a similar investigation in the past two weeks.
7.Subjects willing to come for regular follow up visits.
8.Subjects ready to follow instructions during the study period.  
 
ExclusionCriteria 
Details  1.Infection, allergy on the tested area.
2.Skin allergy, antecedents or atopic subjects.
3.Athletes and subjects with history of excessive sweating.
4.Cutaneous disease which may influence the study result.
5.Subjects on oral corticosteroid.
6.Subjects participating in any other cosmetic or therapeutic trial.
7.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the investigational products on healthy human subjects   Approximately 9 days for each subject. 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   22/03/2021 
Date of Study Completion (India) 31/03/2021 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study Objective:

The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.

Study Population:

24 healthy human volunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).

Duration of study:

Approximately 9 days for each volunteer.

 Test Site:   

Between the scapula and waist of the subjects, the test site should be free of pigmentation, pimple, hair, mole or any dermatological condition that can interfere with the reading.

Patch Application:

The loaded patch system is applied at the test site of study subjects starting with the lower edge of the patch system and slowly pressing upwards till the top edge in order to squeeze out the air.

Patch Methodology:

The patch will be kept for 24 hours. The patch will be removed after 24 hours. The test sites will be wiped with a clean tissue to remove any residue prior to evaluation. Dermatologist will visually assess the skin condition of each test site at the following frequencies- 20-30 minutes’ post patch removal (0 hour reading), 24 hrs and 7 days’ post patch removal as per Draize scoring system.

 
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