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CTRI Number  CTRI/2018/05/014262 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On: 31/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Monitoring and comparing the improvement of hair growth using minoxidil(5%) versus Minoxidil(5%) and Finasteride (0.1%) combination in subjects male pattern baldness 
Scientific Title of Study   Study of the safety and efficacy of topical minoxidil(5%) versus Minoxidil(5%) and Finasteride (0.1%) combination in the treatment of androgenetic alopecia in men  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alex James 
Designation  Pg Resident  
Affiliation  Father muller medical college  
Address  Room no 65 Department of Dermatology Father muller medical college Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9566609588  
Fax    
Email  dralexj2013@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jacintha Martis 
Designation  Professor 
Affiliation  Father muller medical college  
Address  Room no 65 Department of dermatology Father muller medical college Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845148112  
Fax    
Email  dr_martisj@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Alex James 
Designation  Pg Resident  
Affiliation  Father Muller Medical College 
Address  Room no 65 Department of Dermatology Father Muller Medical College Kankanady Mangalore 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9566609588  
Fax    
Email  dralexj2013@gmail.com  
 
Source of Monetary or Material Support  
Dr Alex James Room no 65 Department of dermatology Father Muller medical college Kankanady Mangalore 
 
Primary Sponsor  
Name  Dr Alex James 
Address  ROOM NO 65 DEPARTMENT OF DERMATOLOGY FATHER MULLER MEDICAL COLLEGE KAKANADY MANGLORE  
Type of Sponsor  Other [self] 
 
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 Alex James  FATHER MULLER MEDICAL COLLEGE   Room no 65 Department of Dermatology Mangalore
Dakshina Kannada
KARNATAKA 		 9566609588

dralexj2013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Androgenetic alopecia in men ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Minoxidil 5%  Minoxidil 5% should be applied 1ml twice daily over the scalp for 4 months  
Comparator Agent  Morrf  Minoxidil(5%) + Finasteride (0.1%) should be applied 1 ml twice daily over the scalp for 4 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Male patients between 18-45 years.
2.Patients with grade II –IV of modified Norwood Hamilton classification of AGA.
3.Men willing to use the same shampoo and maintain same hair length and colour for the entire duration of the study.
 
 
ExclusionCriteria 
Details  1.Patients who are not willing for the study.
2.Patients with dermatological disorders on the scalp other than AGA.
3.Patients with serious cardiovascular, renal or hepatic disease.
4.Patients with history of drug hypersensitivity.
5.Patients who are using any other therapy for AGA.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in hair growth   Increase in hair growth after and growth will be assessed at initial visit, 8th week and 16th week 
 
Secondary Outcome  
Outcome  TimePoints 
itching, erythema and dandruff.  To be assessed at initial visit, 8th week and 16th week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2016 
Date of Study Completion (India) 15/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Cranwell W, Sinclair R. Male Androgenetic Alopecia. In: De Groot LJ, Chrousos G, Dungan K, et al., editors. Endotext. South Dartmouth. 2000.   
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Androgenetic alopecia is a genetically determined pattern of baldness. it causes an alteration in hair cycle dynamics that is characterised by stepwise miniaturisation of the hair follicle. This leads to vellus transformation of the terminal hair follicles. Genetic factors and androgens both play a key role in causing androgenetic hair loss. Several studies have been conducted testing the benefits of topical minoxidil and oral finasteride for the treatment of androgenetic alopecia. However, studies to prove the benefits of its combination are few in number. Hence this comparative study is undertaken. objective of the study is to compare the safety and efficacy of topical minoxidil(5%) and minoxidil(5%) +finasteride (0.1%) combination adult male patients with androgenetic alopecia and determine the various clinical patterns of androgenetic alopecia. 40 patients are enrolled in the study in which 20 patient will be treated with minoxidil(5%)(GROUP A) and other 20 will be treated with Minoxidil(5%) +Finasteride (0.1%) combination(GROUP B). Both the group will be instructed to apply 1 ml topically over the scalp. Follow up will be done every month for 4 months. Dermoscopic images of the scalp will be taken at initial visit, 8th week and 16th week. Patient will be assessed for hair growth using 5 point scale grade 1(Markedly improved), grade 2 (Moderately improved), grade 3 (slightly improved), grade 4 (unchanged), grade 5 (worsened). patient were assessed for any adverse effects of therapy at each visit.Data will be collected and analysed by frequency, percentage, Mean, standard deviation and chi-square test. 
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