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CTRI Number  CTRI/2017/06/008742 [Registered on: 02/06/2017] Trial Registered Retrospectively
Last Modified On: 16/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patch testing for safety]  
Study Design  Single Arm Study 
Public Title of Study   Patch Test Study for Safety Testing of Cosmetics 
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   
Secondary IDs if Any  
Secondary ID  Identifier 
1617CICL653 (1617CICL653B) Version 01 dated 13 Feb 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Annie Jain MD 
Designation  Principal Investigator 
Affiliation  CIDP Biotech India Pvt. Ltd 
Address  32B First Floor, Rajinder Nager, Pusa Road New Delhi

New Delhi
DELHI
110005
India 
Phone  09582645711  
Fax    
Email  a.jain@cidp-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Annie Jain MD 
Designation  Principal Investigator 
Affiliation  CIDP Biotech India Pvt. Ltd 
Address  32B First Floor, Rajinder Nager, Pusa Road New Delhi

New Delhi
DELHI
110005
India 
Phone  09582645711  
Fax    
Email  a.jain@cidp-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Geet Agrawal 
Designation  Study Manager 
Affiliation  CIDP Biotech India Pvt. Ltd 
Address  32B First Floor, Rajinder Nager, Pusa Road New Delhi

New Delhi
DELHI
110005
India 
Phone  1140793385  
Fax    
Email  g.agrawal@cidp-cro.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  ITC Life Sciences Technology Centre 
Address  Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India  
Type of Sponsor  Other [Research and Development] 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preksha Singh MD  CIDP Biotech India Pvt. Ltd.  32 B First Floor, Rajinder Nagar, Pusa Road New Delhi-110005
New Delhi
DELHI 		 08130531935

p.singh@cidp-cro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee - ADITYA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult subjects in the age group of 18 years to 55 years (both inclusive) will be selected  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Leave On (Perfume Spray) 2.Leave On (Cologne Spray) 3.Leave On (Perfume Spray) 4.Leave On (Perfume Spray) 5.Rinse Off (Hand wash) 6.Rinse Off (Hand wash) 7.Skin Leave On (Spray) 8. Skin Leave On (Spray) 9. Leave On (Perfume Spray) 10. Leave On (Perfume Spray)  Leave On Products (375,376,8060,8067,6183A,6183B,77103A,77103B):These are applied as such without any dilution Rinse Off Products (73008B,73008C):8% w/W sample solution: 8gms of test samples is dissolved in 80gms of distilled water and made upto 100 gm solution using distilled water 
Comparator Agent  Sodium Lauryl Sulphate (SLS) 3% Solution   3% Solution 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Healthy male and female subjects in the age group of 18-55 years (both age inclusive)
2. Subjects with Fitzpatrick skin type III to V
3. Subjects willing to give a voluntary written informed consent
4. Subjects willing to maintain the test patches in designated positions for 24 Hours
5. Subjects having not participated in a similar investigation in the past two weeks
6. Subjects willing to come for regular follow up visits
7. Subjects ready to follow instructions during the study period
8. Subjects without any open wounds, cuts, abrasions, irritation symptoms 
 
ExclusionCriteria 
Details  1. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application
2. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results
3. Subject is Pregnant or Lactating
4. Athletes and subjects with history of excessive sweating
5. Subjects on oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results
6. Subjects participating in any other cosmetic or therapeutic trial
7. Subjects with 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   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety assessment of investigational products for irritation potential using Draize scale.  Draize scoring to be done at 0 hr, 24 hr and day 7 of patch removal 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
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   N/A 
Date of First Enrollment (India)   22/05/2017 
Date of Study Completion (India) 30/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
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)  

Objective :The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.Primary irritation patch test is used widely for the evaluation of safety of cosmetics in humans.

Sample Size :Twenty four (male and female, in a ratio of 1:1) adult subjects in the age group of 18 years to 55 years (both inclusive) 

Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance.

By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs and is done as per BIS standard (IS4011:1997)

 
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