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CTRI Number  CTRI/2025/08/092211 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceuitcal]  
Study Design  Other 
Public Title of Study   The Study to check the safety and effectiveness of product on human volunteers  
Scientific Title of Study   To evaluate and compare the in vivo safety and efficacy of Skin Care Formulations versus Untreated control in terms of the moisturization & skin water barrier function on healthy minor girls & boys subjects  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-HD01-4B-MY25; Version: 01; Dated: 23/07/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Yadav 
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  poojayadav@mascotspincontrol.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja Yadav 
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  poojayadav@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  
Baby Forest Ayurveda Private Limited A-55, BLOCK–A, SECTOR– 83, NOIDA DISTT. GAUTAMBUDH NAGAR a, 55, Sector 9, Noida, Uttar Pradesh 201301, India 
 
Primary Sponsor  
Name  Baby Forest Ayurveda Private Limited  
Address  A-55, BLOCK–A, SECTOR– 83, NOIDA DISTT. GAUTAMBUDH NAGAR a, 55, Sector 9, Noida, Uttar Pradesh 201301, India 
Type of Sponsor  Other [Ayurvedic baby Care product 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 Pooja Yadav  Mascot Spincontrol India Pvt. Ltd.   Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 02243349191

poojayadav@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  having dry skin type 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Khilta Mukhra Baby Face Cream (BFFC/04)  20 µl 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 48 hours.  
Intervention  MOH MALAI BABY BODY LOTION (BFBL/03)  20 µl 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 48 hours. 
Intervention  Nikhrae Kesh Baby Shampoo (BFBS/05)  20 µl 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 48 hours. 
Intervention  Sampoorna Snan Baby Body Wash (BFBBW/06)  20 µl 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 48 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  12.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1)Indian girl & boys subjects.
2)Healthy subjects
3)Skin is healthy on the studied anatomic unit.
4)Subject having dry skin type.
 
 
ExclusionCriteria 
Details  1. Having refused to give her/his assent by not signing the consent form
2. Taking part in another study liable to interfere with this study
3. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
4. Having a progressive asthma (either under treatment or last fit in the last 2 years)
5. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
6. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
7. Being epileptic.
8. 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)
9. Having cutaneous hypersensitivity.
10. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
11. Having undergone a surgery requiring a general anesthetic of more than one hour in the past 6
months.  
 
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 
Moisturization & skin water barrier function   Baseline, 30 minutes, 24 Hours and 48 Hours after product application  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   12/08/2025 
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="20" 
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 will be to evaluate and compare the in-vivo safety and efficacy of Skin Care Formulations versus Untreated control in terms of the moisturization & skin water barrier function on healthy minor girls & boys subjects.

 

The evaluation will be performed using:Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation : Efficacy, Corneometry, Tewametry

 

POPULATION : 66 minor girls & boys subjects will be selected for the study. The study will be conducted in 2 groups 33 (16 boys & 17 girls / 17 boys & 16 girls) subjects in each group.

Group A: - Product A & Product B

Group B: - Product C & Product D

The subjects selected for this study will be healthy minor aged between 12 and 17 years, having dry skin type.

 

STUDY DURATION : 48 hours following the application of the product.


 
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