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CTRI Number  CTRI/2024/02/063225 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of dutasteride plus minoxidil solution vs minoxidil solution alone in male pattern hair loss 
Scientific Title of Study   Comparison of efficacy of topical 0.025 % Dutasteride plus 5 % Minoxidil solution vs topical Minoxidil 5 % alone in male androgenetic alopecia - a randomised open label pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bikash Ranjan Kar 
Designation  Professor and HOD 
Affiliation  IMS and SUM Hospital 
Address  Department of DVL IMS and SUM Hospital K 8, Kalinga Nagar Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  9937428181  
Fax    
Email  karbikash@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bikash Ranjan Kar 
Designation  Professor and HOD 
Affiliation  IMS and SUM Hospital 
Address  Department of DVL IMS and SUM Hospital K 8, Kalinga Nagar Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  9937428181  
Fax    
Email  karbikash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bikash Ranjan Kar 
Designation  Professor and HOD 
Affiliation  IMS and SUM Hospital 
Address  Department of DVL IMS and SUM Hospital K 8, Kalinga Nagar Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  9937428181  
Fax    
Email  karbikash@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM Hospital, K-8, Kalinga Nagar, Bhubaneswar, Odisha 
 
Primary Sponsor  
Name  none 
Address  NOT APPLICABLE 
Type of Sponsor  Other [Self-sponsored] 
 
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 
Bikash Ranjan Kar  IMS and SUM Hospital  Department of DVL K 8, Kalinga Nagar Bhubaneshwar
Khordha
ORISSA 		 9937428181

karbikash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, IMS AND SUM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  5% minoxidil solution  1 ml of topical minoxidil 5% twice daily for 24 weeks 
Intervention  Topical dutasteride 0.025% plus 5% minoxidil solution  1ml of topical dutasteride 0.025% at morning time plus 1 ml of topical 5% minoxidil solution at night time daily for 24 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.All males aged 18-45 yrs of age
2. Males with (Hamilton Norwood Scale II-IV)
3. Who are not currently undergoing any hair treatment and have not undergone any in the last 3 months 
 
ExclusionCriteria 
Details  1.Severe hypertension, moderate hypertension on antihypertensive therapy.
2.Cardiovascular dysfunction
3.History of minoxidil hypersensitivity
4.Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors
5.Psychiatric or scalp disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Clinical photographic assessment and quantitative assessment using densitometer
2. Hair density calculation  		 every monthly for 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The number of vellus hairs, terminal hairs determined by their thickness in the specific square inch area  every monthly for 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/03/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

      The patients meeting all the inclusion criteria and not meeting any exclusion criteria shall be considered to participate in the study.
·       A detailed history including the duration of disease , associated medical conditions , treatment history and family history is to be taken.
·       The patients are randomized according to random  number generator and allocated to two interventional group.
·       Assessor shall be blinded.
·       Two medications shall be given.
·       One group will be given topical dutasteride 0.025% morning time and 5% minoxidil solution at night time for 24 weeks.
·       The other group will be given topical minoxidil  5% twice daily for 24weeks.
·       Follow up is done at baseline and after recruitment into trial every 4weeks for 24weeks.
·       The outcome will be based on photographic assessment  and quantitative assessment using densitometer.
·       Any patient developing side effects  or severe pain  shall be pulled out of intervention.
Clinical photographic assessment and quantitative assessment using densitometer will be done every 4 weeks till 24weeks with due care the patients identity is not revealed. 

 
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