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CTRI Number  CTRI/2025/11/097185 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   Clinical study to check the moisturizing effect of skincare product 
Scientific Title of Study   Evaluation of the moisturization effect of skin care formulation (Cebhydra Intense) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-HD02-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 dry skin on inner forearms  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cebhydra Intense  2microlitre per cm² of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncovered for absorption. Water should not be applied on site for 24 hours.  
Comparator Agent  Untreated control site  Another site of 3 × 3 cm² marked on the inner forearm is kept as an untreated control site. No product application is done on the untreated control site.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1)Indian male and female subjects
2)Healthy 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 40 years of age.
4)Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar).
5)Having dry skin on inner forearms with corneometry reading of less than 30.
 
 
ExclusionCriteria 
Details  1)For Female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2)Having started, changed or stopped a hormonal treatment (e.g., hormonal contraception, Hormonal Replacement Therapy, thyroid) in the past 3 months
3)Having taken an oral retinoid-based treatment in the past 6 months.
4)Having had a local retinoid-based treatment on the studied areas in the previous month.
5)Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week
6)Having applied a moisturizing product on the studied areas in the 5 days preceding the start of the study. (only hands cleaned with water is accepted)
7)Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week
8)Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
9)Having practiced intensive sports during the day prior to the T0 measurements
10)Having wounds, Scars, sunburns, tattoos and piercing on test site.
11)Having applied another product than water on the studied areas in the morning of the T0 measurements
12)Having had an intensive UV exposition on the forearms (solariums, sun) during 5 days prior to T0 measurements.
13)Having used any skin care products as well as skin care cleansers such as bath/shower oils on the forearms during 5 days prior to T0 measurements.
14)Having hair on test site.
15)Refusing to follow the restrictions below during the study:Do not take part in any family planning activities leading to pregnancy and breastfeeding, 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), During the study: Do not use other cosmetic products than the tested product to the studied areas, Do not have beauty treatment (e.g. scrub, manicure self-tanning product) ,Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.), Do not drink/ eat caffeine-based products (coffee, cola, tea), alcohol, highly spiced food, nor smoke , Do not practice sport, Do not apply any product on inner forearms including water, Do not wipe their inner forearms, Do not wear jewels on the wrists, Do not have an intensive UV exposition on the inner forearms (solariums, sun).
16) Between T0 and T+24 hours after Product application measurements:Do not use skin care products on the inner forearms, Do not wash the inner forearms, Do not use surfactant containing product on the test site on inner forearms, Daily morning hygiene with water accepted except on inner forearms.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percent improvement in capacitance value assessed through corneometry  Baseline, 24 Hours after product application. 
 
Secondary Outcome  
Outcome  TimePoints 
Percent improvement in capacitance through corneometry, Percent reduction in transepidermal water loss (TEWL)through tewametry, Percent improvement in skin softness through dermatologist evaluation , Percent panel agreement for moisturization effect based on subject self-evaluation questionnaire, • Subject self-evaluation questionnaire score for cosmetic appeal and safety, • Adverse events (AEs) and serious adverse events (SAEs) reported by the subject and the dermatologist  Baseline, 30 minutes, 4 hours, 8 hours, 24 Hours after product application. 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   21/11/2025 
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="1"
Days="7" 
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 is to evaluate the moisturization effect of skincare formulation – Cebhydra Intense on healthy human male & female subjects.

The evaluation will be performed using: Subject Self Evaluation (SSE) Questionnaire (Moisturization Effect & Safety), Subject Self Evaluation (SSE) Questionnaire (Cosmetic Appeal), Dermatological Evaluation: Safety, Dermatological Evaluation: Skin Softness, Corneometry, and Tewametry.

STUDY POPULATION:
About 16–17 male and 16–17 female subjects will be selected for this study.

Enrollment: 16–17 male and 16–17 female subjects will be enrolled.
Completion: 15 male and 15 female subjects are expected to complete the study.

The subjects to be selected for this study will be healthy males and females aged between 18 and 40 years, having dry skin on the inner forearms with a corneometer reading of <30.

STUDY DURATION:
The study will last for 24 hours for each subject following the application of the product on the forearm.

 

 
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