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CTRI Number  CTRI/2022/06/043384 [Registered on: 21/06/2022] Trial Registered Prospectively
Last Modified On: 16/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [skin care formulations]  
Study Design  Single Arm Study 
Public Title of Study   Safety assessment of Cosmetic Product 
Scientific Title of Study   Evaluation of irritation potential of Skin care formulation on healthy human subjects having varied skin types  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
D01-6Q30-KD-AL22; Version No.: 01; Dated: 27/04/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raji Patil 
Designation  Investigator 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India

Mumbai
MAHARASHTRA
400013
India 
Phone  02243349191  
Fax    
Email  raji@mascotspincontrol.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Raji Patil 
Designation  Investigator 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India


MAHARASHTRA
400013
India 
Phone  02243349191  
Fax    
Email  raji@mascotspincontrol.in  
 
Details of Contact Person
Public Query  
Name  Mr Mohit Lalvani 
Designation  Study Director 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India

Mumbai
MAHARASHTRA
400013
India 
Phone  02243349191  
Fax    
Email  mohit@mascotspincontrol.in  
 
Source of Monetary or Material Support  
MASCOT-SPINCONTROL India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India  
 
Primary Sponsor  
Name  Kama Ayurveda Pvt Ltd  
Address  3 K Commercial Circle, Jungpura Extension, New Delhi – 110014  
Type of Sponsor  Other [FMCG] 
 
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 
Dr Raji Patil  Mascot Spincontrol India Pvt. Ltd.   3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA 		 02243349191

raji@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  Varied skin Types  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kumkumadi oil – VR (PUIF AROMA) (21A4552 – 02/2022)  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 Sodium Lauryl Sulphate)  40 microliters of 1% w/w Sodium Lauryl Sulphate 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.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Healthy Human Subjects
2) Skin should be healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
3) Subjects willing to come for regular follow up and ready to follow instructions during the study period.
4) Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination)
 
 
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, Poriasis, 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 
Dermatological safety / Irritation potential on skin  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)= "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)   21/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/06/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="8" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Single Application, occlusive, Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.

Objective: To evaluate the irritation potential on healthy human subjects of Skin Care Formulation.

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: 24 healthy subjects (12 males + 12 females) with varied skin types.

The distribution of volunteers as per skin type will be as follows: Oily skin – 3 Females + 3 Males, Normal skin – 3 Females + 3 Males, Dry skin – 3 Females + 3 Males, Combination skin – 3 Females + 3 Males

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

   

 
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