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CTRI Number  CTRI/2018/05/013752 [Registered on: 08/05/2018] Trial Registered Prospectively
Last Modified On: 07/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patch test]  
Study Design  Other 
Public Title of Study   Safety assessment of products on skin 
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 
SLS-CT-0004-18-PIPT, Version 01 dated 19 Apr 18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKSenthil Kumar 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and Research Pvt Ltd 
Address  Door.no 29A, Clinical trail unit, SpinoS Life Science and Research Pvt Ltd.,Krishna Madhuravanam, Vellakinar Pirivu, Thudiyalur, Coimbatore, Tamil Nadu, India.

Coimbatore
TAMIL NADU
641029
India 
Phone  9994689336  
Fax    
Email  senthilkumar.k@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  DrKSenthil Kumar 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and Research Pvt Ltd 
Address  Door.no 29A, Clinical trail unit, SpinoS Life Science and Research Pvt Ltd.,Krishna Madhuravanam, Vellakinar Pirivu, Thudiyalur, Coimbatore, Tamil Nadu, India.


TAMIL NADU
641029
India 
Phone  9994689336  
Fax    
Email  senthilkumar.k@spinoslifescience.com  
 
Details of Contact Person
Public Query  
Name  DrKSenthil Kumar 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and Research Pvt Ltd 
Address  Door.no 29A, Clinical trail unit, SpinoS Life Science and Research Pvt Ltd.,Krishna Madhuravanam, Vellakinar Pirivu, Thudiyalur, Coimbatore, Tamil Nadu, India.


TAMIL NADU
641029
India 
Phone  9994689336  
Fax    
Email  senthilkumar.k@spinoslifescience.com  
 
Source of Monetary or Material Support  
SpinoS Life Science and Research Pvt Ltd., No.29 A, “Krishna Madhuravanam”, Vellakinar Pirivu, Thudiyalur, Coimbatore - 641029, Tamil Nadu, India. 
 
Primary Sponsor  
Name  ITC Life Sciences Technology Centre 
Address  Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India 
Type of Sponsor  Other [Cosmetic company] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrKSenthilKumar  SpinoS Life Science and Research Pvt Ltd  Door No.29A,Clinical trail Division,Krishna Madhuravanam, Vellakinar Pirivu,Thudiyalur, Coimbatore, Tamil Nadu, India.
Coimbatore
TAMIL NADU 		 9994689336

senthilkumar.k@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee Ashwin Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Fasting 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
Comparator Agent  patch test  applied 01 time and it remain 24 Hrs after that skin will be monitored 
 
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 the ages 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 patch test in position for 24 hours.
5)Subject 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)Athletes and subjects with history of excessive sweating.
4)Subjects on oral corticosteroid.
5)Subjects participating in any other cosmetic or therapeutic trial.
6)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   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate dermatological safety  Visit 01, 02, 03, 04 and 05 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
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)   15/05/2018 
Date of Study Completion (India) 23/06/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Publication not yet done 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. 20 test products will be tested against 01 control with 24 subjects. total study duration is 10 days. 
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