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CTRI Number  CTRI/2020/10/028452 [Registered on: 16/10/2020] Trial Registered Prospectively
Last Modified On: 30/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [N/AP]  
Study Design  Single Arm Study 
Public Title of Study   Safety assessment of products on skin  
Scientific Title of Study   Evaluation of irritation potential of Skin Care formulation on healthy human subjects 
Trial Acronym  N/AP 
Secondary IDs if Any  
Secondary ID  Identifier 
D01-6Q18-TE-SR20; Version: 01; Dated: 22/09/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddheshwar Mathpati  
Designation  Investigator  
Affiliation  Mascot Spincontrol India Pvt. Ltd.  
Address  Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-43349191   
Fax    
Email  siddheshwar@mascotspincontrol.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddheshwar Mathpati  
Designation  Investigator  
Affiliation  Mascot Spincontrol India Pvt. Ltd.  
Address  Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-43349191   
Fax    
Email  siddheshwar@mascotspincontrol.in  
 
Details of Contact Person
Public Query  
Name  Mr Mohit Lalvani  
Designation  Study Director 
Affiliation  Mascot Spincontrol India Pvt. Ltd.  
Address  Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-43349191   
Fax    
Email  mohit@mascotspincontrol.in  
 
Source of Monetary or Material Support  
Not Applicable  
 
Primary Sponsor  
Name  TTK Healthcare Limited  
Address  Research and Development No.3, Thiruneermalai Road, Chrompet, Chennai – 600 044 Tamil Nadu, India. 
Type of Sponsor  Other [FMCG] 
 
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 Siddheshwar Mathpati   Mascot Spincontrol India Pvt. Ltd.   Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 022-43349191

siddheshwar@mascotspincontrol.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethos- An Institutional Ethics committee (Mumbai)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Skin Type 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Negative Control (0.9% Isotonic saline solution) Positive Control (1% w/w SLS)  1) Patch preparation for Negative control a) 40 μl of 0.9% Isotonic Saline Solution is transferred to previously numbered Aluminum Finn Chamber with an appropriate sized disk of Whatman no. 3 filter paper with the help of Micropipette. b) The Finn chambers with the 0.9% Isotonic Saline Solution loaded will then be taped onto the back of subjects. 2) Patch preparation for Positive control: a) Sodium Lauryl Sulphate solution: 1% w/w solution of SLS in distilled water will be prepared 0.04 ml or 40 μl of the 1% w/w SLS solution will be loaded onto a Whatman filter paper disc, placed in clean Aluminum Finn Chamber. b) The Finn chamber with the loaded 1% w/w SLS solution will be taped onto the back of subject. 
Intervention  Sample A (ST20001T) Sample B (ST2002T) Sample C (ST2003T)  For sample A, B and C: a) 1 cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. b) 0.02 ml or 20 μl of test products will be loaded onto the filter paper disc in a dropwise manner and let to evaporate prior to loading the remaining 0.02ml or 20 μl of test products in a similar manner. c) Once the products get completely evaporated, the Whatman no. 3 filter paper will be lifted and the site will be left as it is for upto half an hour prior to occluding the patch. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  emale and male Asian Indian subjects.Healthy human subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) Subjects willing to come for regular follow up and ready to follow instructions during the study period.  
 
ExclusionCriteria 
Details  For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing
(whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety assessment of products   Baseline,0 hrs,24 hrs and 7 days  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/10/2020 
Date of Study Completion (India) 26/10/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

bjective: To evaluate the irritation potential on healthy human subjects of Skin Care Formulations.

Duration of study: 8 days of study

Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application)

                  T1(Patch removal, Evaluation of test sites by Dermatologist

                 T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal),                   

T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)

Population of 24 healthy subjects (12 males + 12 females)

The test area is checked for erythema and oedema caused due to the products and compared with positive control.

  
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