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CTRI Number  CTRI/2025/10/096537 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceuitcal ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of face cleansing in improving skin conditions 
Scientific Title of Study   A clinical study to assess the efficacy of test products in improving biophysical properties of skin upon face cleansing. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-NF03-UV-OR25; 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  
Hindustan Unilever Limited, Unilever House, B.D. Sawant Marg, Chakala, Mumbai- 400 099  
 
Primary Sponsor  
Name  Hindustan Unilever Limited 
Address  Unilever House, B.D. Sawant Marg, Chakala, Mumbai- 400 099  
Type of Sponsor  Other [Personal Care or Beauty Industry] 
 
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  with dull skin  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CC01  The product is applied on the face, gently lathered for 15 seconds, and rinsed off with water. The face is then patted dry. The total duration of application is 3 days 
Intervention  DF21  The product is applied on the face, gently lathered for 15 seconds, and rinsed off with water. The face is then patted dry. The total duration of application is 3 days 
Intervention  LG76  The product is applied on the face, gently lathered for 15 seconds, and rinsed off with water. The face is then patted dry. The total duration of application is 3 days 
Comparator Agent  Nil  NA 
Intervention  RT45  The product is applied on the face, gently lathered for 15 seconds, and rinsed off with water. The face is then patted dry. The total duration of application is 3 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1)Healthy female volunteers
2)Volunteers with dull skin
3)Volunteers with dark spots
4)Volunteer in good health condition as per the medical screening criteria
5)Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
6)Volunteers agreeing to comply with following study restrictions:
7)Willing to refrain from application of any other product/treatment on their face during wash off and treatment phase
8)Not to apply any cosmetic, skin care product or home remedies or any other face cleanser/wash/soap etc at home during the study period 
 
ExclusionCriteria 
Details  1)Volunteer pregnant or planning to become pregnant.
2)Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
3)Volunteers with any signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
4)Volunteers having chronic illness or had major surgery in the last year.
5)Volunteers undergoing any treatment of any skin condition on body.
6)Volunteers known to have allergies to cosmetics
7)Volunteers taking any food supplements
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in Brightness, Hydration
 		 Baseline, Day 1, Day 2, Day 3 
 
Secondary Outcome  
Outcome  TimePoints 
Safety assessments like redness and dryness  Baseline, Day 1, Day 2, Day 3 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   Phase 2 
Date of First Enrollment (India)   07/11/2025 
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="0"
Days="15" 
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  

Volunteers are recruited based on inclusion and exclusion criteria and undergo 3 days of washout period. On Day 1 baseline (technical & dermatological) assessments are done. Volunteers and provided with face cleansers to apply on  the face at the venue. There are 4 test groups in the study with different wash frequencies per day. Volunteers apply the product for 3 consecutive days and all assessments done post wash. All technical and dermatological visual assessments were compared vs baseline.

 
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