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CTRI Number  CTRI/2022/02/040485 [Registered on: 22/02/2022] Trial Registered Prospectively
Last Modified On: 05/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Other 
Public Title of Study   To Evaluate Efficacy and Safety of KeraScalp Hair Serum in subjects with Mild to Moderate Alopecia of Scalp. 
Scientific Title of Study   An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of KeraScalp Hair Serum in subjects with Mild to Moderate Alopecia of Scalp 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B01769, Version 01, 02 Feb 22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parth Joshi 
Designation  Principal Inestigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax  917966219549  
Email  pjoshi@ofacto.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parth Joshi 
Designation  Principal Inestigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India


GUJARAT
380054
India 
Phone  8000085049  
Fax  917966219549  
Email  pjoshi@ofacto.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Sethi 
Designation  Director - Consumer Research 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax  917966219549  
Email  ssethi@ofacto.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  A Menarini India Private Limited 
Address  2102, Tower 3, One International Centre (formerly India bulls Finance Centre), Senapati Bapat Marg, Elphinstone Road (W), Mumbai 400 013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parth Joshi  Cliantha Research  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT 		 8000085049
917966219549
pjoshi@ofacto.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L648||Other androgenic alopecia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KeraScalp Hair Serum  Neat application, approx. 2 ml once daily when scalp and hair are dry for duration of 90 days. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Age: 18 to 60 years (both inclusive) at the time of consent.
2) Sex: Healthy male or non-pregnant/non-lactating female.
3) Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrolment.
4) Subjects generally in good health.
5) Male subjects with Norwood Pattern II to IV of hair loss and female subjects with Ludwig Scale I to II of hair loss.
6) Subjects agreeing to undergo blood test for Hb and Thyroid to rule out any abnormalities which may affect treatment.
7) Subjects willing to refrain from any other treatment for the main indications for which the study test products are being given during the course of the study.
8) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair fall treatment/ hair products other than the test product for the entire duration of the study.
9) Subjects who have used other marketed product for hair fall control in the past.
10) Subject willing to use test product throughout the study period as instructed.
11) Subjects must be able to understand and provide written informed consent to participate in the study.
12) Subjects should be willing and able to follow the study protocol to participate in the study.
13) Subjects should be willing to allow to take photos of affected areas during the study duration. 
 
ExclusionCriteria 
Details  1) Pregnant or breastfeeding or planning to become pregnant during the study period.
2) History of any dermatological condition of the scalp other than hair loss and/or dandruff.
3) History of prior use of scalp hair growth treatment within 3 months.
4) History of any prior hair growth procedures (e.g., hair transplant or laser).
5) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
6) History of alcohol or drug addiction.
7) Subjects using other marketed hair fall control products during the study period.
8) Subjects who have plans of shaving of scalp hair during the course of the study.
9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
11) Subjects having a history or present condition of an allergic response to any cosmetic products or ingredient of study product.
12) Subjects with hair loss due to Autoimmune disorder/ Chemotherapy/ immunosuppressive drugs/ any major illness/ PCOS etc by history
13) Subjects participating in other similar cosmetic or therapeutic trial within last two weeks.
14) Any other condition which could warrant exclusion from the study, as per the Dermatologist’s/investigator’s discretion. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of test product on anagen and telogen ratio by hair pluck test and microscopic evaluation   baseline i.e Day 01, after treatment on Day 30, Day 90 and at end of follow up visit i.e. Day 120 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of test product on Hair thickness and Hair density by CASlite Nova   baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
To assess the effect of test product on Hair Fall Reduction by counting no. of hair break after 60 second combing method   baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
To assess the efficacy of the test product on Hair Strength by Hair Pull Test   baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
To assess the effect of test product in terms of change in general appearance of scalp hair i.e. Hair Volume (Full – Medium – Small) and Hair Density (Dense – Thinned/Shed) by Dermatologist   baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
Change in general appearance of scalp skin i.e. itchiness, redness, roughness and scaliness of scalp by Dermatologist   baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
Product Perception  baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
Subject Satisfaction Questionnaire  baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
Physician and subject global aesthetic improvement scales (PGAIS and SGAIS)   baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/02/2022 
Date of Study Completion (India) 30/07/2022 
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  

This is an open label, single-arm, clinical study to evaluate efficacy and safety of KeraScalp Hair Serum in subjects with Mild to Moderate Alopecia.

The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.

There are total 10 visits in the study i.e.

·      Visit 01: Screening Visit (07 days prior to Day 01)

·      Visit 02: For Shaving of Test Area (03 days prior to Day 01)

·      Visit 03: Enrolment Visit – Baseline Assessment i.e., Day 01

·      Visit 04: For Shaving of Test Area i.e., Day 27 (± 2 Days) (03 days prior to Day 30)

·      Visit 05: Treatment Phase i.e., Day 30 (+ 2 Days)

·      Visit 06: Treatment Phase i.e., Day 60 (± 2 Days)

·      Visit 07: For Shaving of Test Area i.e., Day 87 (± 2 Days) (03 days prior to Day 90)

·      Visit 08: Treatment Phase i.e., Day 90 (+ 2 Days) , End of Treatment Phase (EOT)          

·      Visit 09: Follow up period i.e., Day 117 (± 2 Days) (03 days prior to Day 120)

·      Visit 10:  Follow up period i.e., Day 120 (+ 2 Days) , End of Study (EOS)

Procedure for Test Product use:  Hair serum to be applied when the hair & scalp are completely dry. Approx. 2 ml of hair serum to be used once daily. Apply serum on the affected area by gentle messaging with the fingertips. Subjects should ensure that they wash their hands with soap after applying hair serum.

Before entering the facility, at security check-post, subjects will be asked for pre-entry scrutiny check for COVID-19 symptoms. Study can be conducted in multiple batches (set of subjects) in order to follow the norms of covid-19 restrictions.

Instrumental assessment, dermatological assessments and questionnaires for hair will be assessed. Digital Photographs will be taken. Safety will be assessed throughout the study by monitoring of adverse events. 
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