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CTRI Number  CTRI/2016/06/007061 [Registered on: 30/06/2016] Trial Registered Prospectively
Last Modified On: 30/06/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   This is a clinical trial wherein the efficacy and safety of Hair serum will be studied on Hair Growth and Hair Fall in healthy adult humans. 
Scientific Title of Study   A prospective, open label clinical study to evaluate the efficacy and safety of Hair serum on Hair Growth and Hair Fall in healthy adult humans. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/47/CAP/APR/16V1.010-MAY-16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr H R Yogeesh 
Designation  Dermatologist 
Affiliation  Life Care Hospital 
Address  # 23/24,Om Complex,Gangothri Circle,BTM 1st Stage,Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9845834908  
Fax    
Email  hryogesh@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kiran Vuppala 
Designation  Senior Manager 
Affiliation  ClinWorld Private Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  kiran@clinworld.org  
 
Details of Contact Person
Public Query  
Name  Mr Hasan Ahmed 
Designation  Founder and Manager 
Affiliation  Xplora Clinical Research Services 
Address  No.14,Maria Niwas,2nd Cross, Chikkadugodi,Dharmaram College post, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9886012598  
Fax    
Email  hasan@xploracrs.com  
 
Source of Monetary or Material Support  
Sami Labs Limited 
 
Primary Sponsor  
Name  Sami Labs Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.560058. 
Type of Sponsor  Other [Marketer & maufacturer of phytonutrients, ayurvedic, herbal extracts, probiotics etc.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr H R Yogeesh  Life Care Hospital  Dermatology centre, # 23/24,Om Complex,Gangothri Circle,BTM 1st Stage,Bangalore 560029.
Bangalore
KARNATAKA 		 9845834908

hryogesh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Life Care Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human volunteers with mild to moderate hair loss 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair Serum  Hair serum 1ml not exceeding 2ml to be applied topically by gentle massage on the scalp twice daily (morning & night) for a period of 90 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Male and female healthy adult subjects ranging in age from 18 to 65 years both inclusive.
2 Willingness to follow the protocol requirements as evidenced by written informed consent.
3 Agree not to use any medication, including vitamins and minerals during or before the course of this study.
4 Mild to moderate hair loss classified as the Norwood-Hamilton type II,III,IV and V in males and Ludwig type I and II in females.
5 Willing to come for all follow-up visits.  
 
ExclusionCriteria 
Details  1 Any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
2 On any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
3 History of hypersensitivity reactions.
4 Participation in a clinical study during the preceding 90 days. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Subject Self Assessment Questionnaire
2 Visual Analog Scale
3 60 Second Hair Comb test
4 Hair Pull Test
5 Clinical photographs of the vertex and superior frontal scalp
6 Investigator Assessment Scale
7 Hair Analysis by Trichoscan Hair density, hair diameter, hair growth rate, or anagen/telogen ratio 		 1 Subject Self Assessment(Screening,Day30,Day60 & Day90)
2 VAS(Screening,Day30,Day60 & Day90)
3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90)
4 Hair Pull Test(Screening,Day30,Day60 & Day90)
5 Clinical photographs(Screening & Day90)
6 Investigator Assessment Scale(Day90)
7 Trichosan Analysis(Screening & Day90) 
 
Secondary Outcome  
Outcome  TimePoints 
1 Adverse Events   1 Adverse Events (Visit 3, Visit 4, Visit 5 and via telephonic follow up to 15 days after Day 90). 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   04/07/2016 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A prospective, open label clinical study to evaluate the efficacy and safety of Hair serum in 40 healthy adult male and female volunteers. The individual subject participation will be for 90 days. The efficacy assessments for the study will be subject self assessment questionnaire, visual analog scale, 60 second hair comb test, hair pull test, clinical photographs, investigator assessment scale, hair analysis by Trichoscan. The secondary assessment for the study include safety outcomes like monitoring of adverse or serious adverse events and abnormal vital signs. 
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