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CTRI Number  CTRI/2017/10/010054 [Registered on: 11/10/2017] Trial Registered Retrospectively
Last Modified On: 10/10/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of topical minoxidil 5% solution alone and a combination topical minoxidil 5% and finasteride 0.1% solution for the treatment of common baldness in men  
Scientific Title of Study   Effectiveness and safety of topical 5 % minoxidil versus combination of 5% minoxidil and 0.1% finasteride in male pattern hair loss: A randomized, comparative, evaluator blinded study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jasleen Kaur 
Designation  Assistant Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Dermatology D block 5th floor Govt. Medical College and Hospital Sector 32

Chandigarh
CHANDIGARH
160030
India 
Phone  9646481249  
Fax    
Email  jasleenksandhu21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jasleen Kaur 
Designation  Assistant Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Dermatology D block 5th floor Govt. Medical College and Hospital Sector 32

Chandigarh
CHANDIGARH
160030
India 
Phone  9646481249  
Fax    
Email  jasleenksandhu21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jasleen Kaur 
Designation  Assistant Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Dermatology D block 5th floor Govt. Medical College and Hospital Sector 32

Chandigarh
CHANDIGARH
160030
India 
Phone  9646481249  
Fax    
Email  jasleenksandhu21@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, D Block 5th Floor Government Medical College and Hospital, Sector 32 Pin-160030 Chandigarh India 
 
Primary Sponsor  
Name  Government Medical College and Hospital Sector Chandigarh 
Address  Department of Dermatology D block 5th Floor Government Medical College and Hospital Sector 32 Chandigarh India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Prof G P Thami  Professor and Head, Department of Dermatology D Block 5th Floor Government Medical College and Hospital Sector 32 Chandigarh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jasleen Kaur  Government Medical College and Hospital, Chandigarh  Department of Dermatology D-Block 5th Floor Govt. Medical College and Hospital
Chandigarh
CHANDIGARH 		 9646481249

jasleenksandhu21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Male pattern hair loss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical minoxidil 5% and finasteride 0.1% combination solution  Twice daily topical application of 1ml of solution on affected scalp for 12 months 
Comparator Agent  Topical Minoxidil 5% solution  Twice daily topical application of 1ml of solution on affected scalp for 12 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Patients with clinical diagnosis of male pattern baldness with Modified Norwood-Hamilton grading III vertex, IV and V
2. Duration of hair loss less than 5 years 
 
ExclusionCriteria 
Details  1. Any systemic or topical treatment for hair loss in last 6 months
2. Any significant cardiovascular diseases like coronary artery disease, congestive heart failure, cardiac dysrhythmias or valvular disease
3. Unrealistic expectations
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The three primary efficacy and safety outcome measures will be the change in total and terminal hair count, scoring of the global photographs by blinded evaluators and adverse events, assessed in both the groups
 		 12 weekly
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary efficacy outcome measure will be the patients subjective hair growth assessment score.  12 weekly 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 4 
Date of First Enrollment (India)   08/09/2017 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is an interventional, prospective, randomised, comparative, parallel group, evaluator -blinded therapeutic trial, including 160 male patients aged 18 to 45 years with clinically diagnosed male pattern hair loss, to compare the effectiveness and safety of application of topical minoxidil 5% only twice daily in 80 patients versus topical combination of minoxidil 5% and finasteride 0.1% twice daily in 80 patients for a period of 12 months in one centre in India. The primary outcome measures will be the total and terminal hair counts, global photograph scoring by blinded evaluators and adverse events assessed in both groups at 3 monthly intervals for a period of one year. the secondary outcome measure will be the subjective improvement assessment by the patients. 
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