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CTRI Number  CTRI/2024/10/075107 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceuitcal]  
Study Design  Other 
Public Title of Study   Safety check of Skin care products 
Scientific Title of Study   To evaluate the irritation potential on healthy human subjects having varied skin types of Skin Care Formulation s 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
D01-6Q02-5A-JY24; Version: 01; Dated: 01/10/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Yadav 
Designation  Principal Investigator 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400025
India 
Phone  02243349191  
Fax    
Email  poojayadav@mascotspincontrol.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja Yadav 
Designation  Principal Investigator 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra


MAHARASHTRA
400025
India 
Phone  02243349191  
Fax    
Email  poojayadav@mascotspincontrol.in  
 
Details of Contact Person
Public Query  
Name  Dr Mohit Lalvani  
Designation  Study Director 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400025
India 
Phone  02243349191  
Fax    
Email  mohit.CTRI@gmail.com  
 
Source of Monetary or Material Support  
Anivium technologies pvt. ltd KH NO779/484, G-19, East Jyoti Nagar, New Delhi, North East Delhi, Delhi, 110093  
 
Primary Sponsor  
Name  Anivium technologies pvt. ltd 
Address  KH NO779/484, G-19, East Jyoti Nagar, New Delhi, North East Delhi, Delhi, 110093  
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  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 Pooja Yadav   MASCOT-SPINCONTROL India Pvt. Ltd.   Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 02243349191

poojayadav@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  with varied skin types  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEWCIOUS- Glow Catalyst face serum  40 microliters of test product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours. 
Intervention  DEWCIOUS- Rice Defense Face cream  40 microliters of test product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours. 
Intervention  DEWCIOUS- Rice Ritual Facewash  8% w/w solution of the product will be prepared in distilled water. 40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours.  
Comparator Agent  Negative Control (0.9% Isotonic saline solution)   40 microliters of 0.9% Isotonic saline solution is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours.  
Comparator Agent  Positive Control (1% w/w SLS)   40 microliters of 1% w/w Sodium Lauryl Sulphate isdispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Asian Indian male and female subjects
2) 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 check-up)
3) Between 18 and 65 years of age
4) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….)
5) Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).  
 
ExclusionCriteria 
Details  1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give his/her assent by not signing the consent form
3 Taking part in another study liable to interfere with this study
4 Being diabetic.
5 Being asthmatic.
6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Dermatological safety of test products, Irritation potential of test products   Baseline, 0 hr , 24 hours & day 8  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Objective: The objective of this study will be to evaluate the irritation potential on healthy human subjects having varied skin types of Skin Care Formulations. 

Duration of study: 8 days 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: 26 healthy subjects (13 males + 13 females). 

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