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CTRI Number  CTRI/2025/11/096753 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   Study to test if a skin care product causes skin reaction in humans 
Scientific Title of Study   Evaluation of the sensitization potential of skin care formulation through Dermatological evaluation – Human Repeat Insult Patch Test Method 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
D01-6Q11-SN-AT25; Version: 01; Dated: 13/10/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niharika Salian 
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  niharika@mascotspincontrol.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Niharika Salian 
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  niharika@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  
Sun Pharmaceutical Industries Ltd. Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063  
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Ltd.  
Address  Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063  
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Mohit Lalvani  Mascot Spincontrol India Pvt. Ltd.   Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 02243349191

mohit.CTRI@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksa- Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Having healthy skin on studied anatomic unit 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cebhydra Intense  Patch application as per BIS standard.0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours.  
Comparator Agent  Negative Control (0.9% Isotonic saline solution)   Patch application as per BIS standard. 0.9% Isotonic Saline Solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. 
 
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)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)
3)Between 18 and 65 years of age.
4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
 
 
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, anti-histamines, 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.
11)The day of the patch application: no cosmetic product must be used (test site clean with water only).
12)Refusing to follow the restrictions below during the study:For female: Do not become pregnant nor breastfeed, Do not take part in another study liable to interfere with this study, Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol), Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
13)Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area
14)Having disorder of the healing (whatever the considered area)
15)Having a rhinitis, allergic conjunctivitis or rhino sinusitis
16)Having an allergy to perfumes and/or preservatives in cosmetic products
17)Having an allergy to plaster
18)Having a food allergy
19)Having a cardiovascular pathology (taking a beta blocker treatment)
20)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
21)Taking a retinoid-based treatment by general or oral route
22)Taking specific treatment on the back
23)Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
24)Having miliaria (prickly heat) on the back.
25)Presenting too many naevi on the back
26)Having high pilosity on the back
27)Having scars, excessive terminal hair or tattoo on the study area
28)Refusing to follow the restrictions below during the study:During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back , Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal), Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches), Do not expose the back to the sun.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of sensitization potential at Induction phase using the Draize scale and in Challenge phase using the ICDRG scale  Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events (AEs) and serious adverse events (SAEs)   Day1, Day2, Day 3, Day 4, Day 5, Day 6, Day 7,Day 8, Day 9, Day 10, Day 11, Day 12, Day 13,Day 14,Day 15, Day 16, Day 17,Day 18, Day 19, Day 20, Day 21, Day 36, day 37,Day 38, Day 39, Day 40 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   11/11/2025 
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="6"
Days="0" 
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  

The objective of this study is to evaluate the sensitization potential of a skin care formulation on healthy human subjects.

The evaluation will be performed using the Dermatological Evaluation: Human Repeat Insult Patch Test Method.

Total duration of the study: 40 days following the first application of the product.

Kinetics: The study will include an induction phase with 21 visits (T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19, and T20), followed by a resting phase of 14 days, and a challenge phase of 5 days (T21, T22, T23, T24, and T25).

The study will be conducted in three phases:

  1. Induction Phase

  2. Resting Phase

  3. Challenge Phase

The Induction Phase will last for 21 days, during which 9 repeated applications of patches will be carried out. The patches will be removed after 24 hours of application and will be evaluated after 24 hours of removal.

 
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