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CTRI Number  CTRI/2024/03/064853 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceuitcal ]  
Study Design  Single Arm Study 
Public Title of Study   Checking of safety of products on human volunteers  
Scientific Title of Study   To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
D01-6Q51-ZC-FR24: Version: 01; Dated: 08/03/2024   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  MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel

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  MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel

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

Mumbai
MAHARASHTRA
400013
India 
Phone  02243349191  
Fax    
Email  mohit.CTRI@gmail.com  
 
Source of Monetary or Material Support  
ITC LIMITED, ITC Life Sciences and Technology Centre,No. 3, st Main Road, Peenya Industrial Area, I Phase Peenya, Bangalore – 560058, INDIA. 
 
Primary Sponsor  
Name  ITC LIMITED 
Address  ITC Life Sciences and Technology Centre, No. 3, 1st Main Road, Peenya Industrial Area, I Phase Peenya, Bangalore – 560058, INDIA. 
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 Raji Patil  Mascot Spincontrol India Pvt. Ltd.   MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
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  with sensitive skin 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Isotonic Saline Solution - Negative control  A single application of about 0.04ml of 0.9% Isotonic Saline, prepared in distilled water is applied under occlusion for 24hrs on the subjects back. 
Comparator Agent  1% Sodium Lauryl Sulphate (SLS) - Positive control   A single application of about 0.04ml of 1% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back. 
Intervention  159-60  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  185-51  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  193-18  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  CN 192-12  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  CN 192-15  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  HCL-033-091a  A single application of about 0.04ml of 1:5v/v of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  HCL-033-091b  A single application of about 0.04ml of 1:100v/v of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  HCL-034-030a  A single application of about 0.04ml of 1:5v/v of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  HCL-034-030b  A single application of about 0.04ml of 1:100v/v of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  HCL-32-062A  A single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back.  
Intervention  HCL-32-063A  A single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back.  
Intervention  MBAW  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  SH192-09  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
Intervention  SH192-14  A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Female and male Asian Indian subjects.
2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
3)Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
4)For females: Urine pregnancy test (UPT) need to done.  
 
ExclusionCriteria 
Details  1)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.
2) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.
3)Having healing disorder in the concerned area.
4)Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
5) Having an allergy to perfumes and/or preservatives in cosmetic products.
6)Having an allergy to plaster / adhesives used in plaster.
7) Having a food allergy.
8)Having a cardiovascular pathology that requires beta blocking treatments.
9)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
10)Taking a retinoid-based treatment by general or oral route.
11)Taking specific treatment on the back.
12) Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
13)Having miliaria (prickly heat) on the back.
14) Presenting too many neavi on the back.
15) Having high pilosity on the back.  
 
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 & 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/03/2024 
Date of Study Completion (India) 09/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="8" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

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

Objective: To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin.

Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermat and Subject, Patch application), T on patch Application Day, T+30mins post patch application, T1(Patch removal, Evaluation of test sites by Dermat), T2(Evaluation of test sites by Dermat 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 35 healthy subjects(17 males + 18 females)

The distribution of volunteers as per skin type will be as follows: Sensitive Combination skin : 4 Females + 4 Males Sensitive Dry skin – 4 Females + 4 Males Sensitive Oily skin – 5 Females + 5 Males Sensitive Normal skin – 4/5 Females + 4/5 Males

 
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