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CTRI Number  CTRI/2022/08/044730 [Registered on: 17/08/2022] Trial Registered Prospectively
Last Modified On: 22/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to check hair fall benefits  
Scientific Title of Study   To evaluate the efficacy of the test product in comparison with a placebo and baseline in improving hair growth rate and hair fall reduction in healthy subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HAIR/MAHS/2022-08 Version 1.0 Dated 14 Jul 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor


KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor


KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@mscr.in  
 
Source of Monetary or Material Support  
Marico Limited 
 
Primary Sponsor  
Name  Marico Limited 
Address  MARKS, plot no:23-C Mahakalli Caves Road Andheri (E) Mumbai-400093  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
None  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 Mukesh Ramnane  MS Clinical Research Pvt. Ltd.  First floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
mukesh.ramnane@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PAY-21  Take approximately 3-5ml of the test product. Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform application. Leave the oil overnight and wash the next day with the provided shampoo. Total duration is 3 months.  
Comparator Agent  PLO-95  Take approximately 3-5ml of the test product. Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform application. Leave the oil overnight and wash the next day with the provided shampoo. Total duration is 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Male and female subjects in general good health.
2. Subjects in the age group 18-45 years (both the ages inclusive).
3. Subjects complaining of hair fall and damage.
4. Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
5. Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement.
6. Male and female subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).
7. Subjects who are willing to give their hair samples for assessments.  
 
ExclusionCriteria 
Details  1. Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2. Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
3. Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4. Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
5. Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems.
6. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7. Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna which will compromise the study.
8. Subjects with chronic illness which may influence the cutaneous state.
9. Subjects participating in other similar cosmetic or therapeutic trial within last three months.
10. Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Significant improvement in hair growth rate.
2.Significant improvement in hair thickness.
3.Significant reduction in hair fall count.
4.Significant improvement in hair density
5.Significant improvement in anagen and telogen ratio 		 At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Significant improvement in hair thinning.
2.Significant improvement in density of vellus hair and terminal hair.
3.overall safety of test product.  		 At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline. 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/08/2022 
Date of Study Completion (India) 18/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Adult male and female subjects with age between 18-45 years (both inclusive) will be screened for eligibility criteria. On screening visit, before starting any study procedure, written informed consent will be obtained.

All baseline assessment like baseline dermatological assessments and imaging will be performed. Post baseline assessments, the selected subjects will be provided with the test product. The subjects will be instructed to use the test product for 90/92 days.

Follow up evaluations will be performed at day 14 & 16, day 30 & 32, day 45/60 and 47/62 and day 60/90 & 62/92.

 
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