FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094086 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceuitcal]  
Study Design  Single Arm Study 
Public Title of Study   Study to assess the safety and effectiveness of the hair product on human volunteers 
Scientific Title of Study   To evaluate in vivo safety and efficacy of hair care formulation in terms of hair growth i.e., improvement in A is to T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength on healthy human subjects. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-7I01-QJ-JE25; Version: 01; Dated: 22/08/2025  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  
Richfeel KHASRA NO. 555/3/2, V.P.O. TAKSAL, Taksal, Parwanoo, Solan, Himachal Pradesh, 173220  
 
Primary Sponsor  
Name  Richfeel 
Address  KHASRA NO. 555/3/2, V.P.O. TAKSAL, Taksal, Parwanoo, Solan, Himachal Pradesh, 173220  
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 Niharika Salian  Mascot Spincontrol India Pvt. Ltd.   Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 02243349191

niharika@mascotspincontrol.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethos- Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  showing initial stage of baldness(L65.9) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NA 
Intervention  Product A  Test product is applied on whole scalp and hair shaft. Once in a day for the period of 84 days. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Indian or Asian male & female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Having androgenetic alopecia of class I-2 to I-4 according to Ludwig Scale for females and class II to III (including III, IIIA and III vertex) according to Norwood Hamilton Scale for males.  
 
ExclusionCriteria 
Details  1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give her/his assent by not signing the consent form
3. Taking part in another study liable to interfere with this study
4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5. Having a progressive asthma (either under treatment or last fit in the last 2 years)
6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Being epileptic.
9. 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)
10. Having cutaneous hypersensitivity.
11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12. Having undergone a surgery requiring a general anesthetic of more than one hour in the past 6
months.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength   Baseline, 28 Days, 56 Days, 84Days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   07/09/2025 
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="5"
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  

OBJECTIVE : The objective of this study will be to evaluate in-vivo safety and efficacy of hair care formulation in terms of hair growth i.e., improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength on healthy human subjects

 

The evaluation will be performed using: Subject’s self-assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Phototrichogram Analysis, Analysis of hair thickness through Dino-lite Digital Microscope, Counting of Fallen Hair after Standardized Combing

 

POPULATION : 36 (18 male and 18 female) subjects are selected for the study. The subjects selected for this study are healthy males & females aged between 30 and 50 years & showing initial stage of baldness, For Males: Hamilton Scale Class II  to III (including III, IIIA and III vertex) ; for Females: Ludwig Scale I-2 to I-4).  

 

STUDY DURATION : 84 days following the first application of the product.

 

 
Close