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CTRI Number  CTRI/2025/09/095177 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL STUDY ON AN INTERVENTION IN MALE PARTICIPANTS WITH HAIR LOSS 
Scientific Title of Study   A Randomised Study to Evaluate the Efficacy and Adverse Effects of Oral Minoxidil and Oral Dutasteride in Androgenetic Alopecia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Boddeda yashaswini 
Designation  postgraduate 
Affiliation  maharajahs institute of medical sciences 
Address  Room number- 25, Department of dermatology, venerology and leprosy, maharajahs institute of medical sciences, nellimarla

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  7702440629  
Fax    
Email  yashaswini.0405@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K.V.T.GOPAL 
Designation  professor and head of the department 
Affiliation  maharajahs institute of medical sciences 
Address  Room number- 25, Department of dermatology, venerology and leprosy, maharajahs institute of medical sciences, nellimarla

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  09440156552  
Fax    
Email  kvtgopal77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Boddeda yashaswini 
Designation  postgraduate 
Affiliation  maharajahs institute of medical sciences 
Address  room number- 25, department of dermatology, venerology and leprosy, maharajahs institute of medical of sciences, nellimarla.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  7702440629  
Fax    
Email  yashaswini.0405@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, Venerology and Leprosy, Maharajahs institute of medical sciences, Nellimarla, Vijaynagaram, Andhra Pradesh, 535217 
 
Primary Sponsor  
Name  Maharajahs institute of medical sciences 
Address  Maharajahs institute of medical sciences, nellimarla, vijayanagaram, 535217 
Type of Sponsor  Private medical college 
 
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 Boddeda yashaswini  Maharajahs institute of medical sciences  Maharajahs institute of medical of sciences, nellimarla, vijayanagaram, 535217
Vizianagaram
ANDHRA PRADESH 
7702440629

yashaswini.0405@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, maharajahs institute of medical sciences   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  Tablet Dutasteride  0.5mg OD oral for 6 months 
Intervention  Tablet Minoxidil  2.5mg OD oral for 6 months 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Male 
Details  All male patients of age group 18 yrs to 60 yrs.

Patient who give their consent to the study.

Patients with androgenetic alopecia

Patient not taking any treatment for androgenetic alopecia since last 6 weeks.

 
 
ExclusionCriteria 
Details  History of usage of anti-androgenic medications, drugs causing hypertrichosis within the past 6 months.
Any systemic illnesses including hypertension, cardiomyopathy, nephropathy, dermatosis involving scalp.
Hypersensitivity to minoxidil.
Smokers or tobacco chewers.
History of breast or prostate cancer.
History of hair transplantation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To access the increase hair thickness and density   Baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Phase 2 
Date of First Enrollment (India)   01/10/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

INTRODUCTION:

Androgenetic alopecia (AGA) is common form of patterned hair loss on the scalp affecting males. There is a gradual decline in the production of hair that may eventually lead to balding. Topical minoxidil and oral finasteride are the only FDA approved drugs for treatment of AGA. Oral minoxidil and oral dutasteride are promising new drugs which may be used in AGA. In this background, the present study is being undertaken to evaluate and confirm and compare the efficacy and adverse effects of oral minoxidil and oral dutasteride in treatment of androgenetic alopecia. Hence the present study has been undertaken.  

A paired student’s t- test will be utilised to compare means before and after the treatment, while a student’s unpaired t-test will be employed to compare means between different procedures. For all statistical analysis, P value <0.05 will be considered as statistically significant.

 

AIM AND OBJECTIVES:

To study the efficacy and adverse effects of oral minoxidil and oral dutasteride in androgenetic alopecia.

MATERIALS AND METHODOLOGY:

Detailed history will be taken and thorough dermatological examination will be performed.

After the diagnosis of Androgenetic alopecia is established, All the patients will be subjected to certain blood tests like Hemogram, viral markers and RBS.

The stage of male pattern baldness will be determined using Modified Norwood Hamilton classification.

A Baseline Macrophotograph of mid-anterior scalp will be taken. A 1cm2 area will be marked and number of hairs within the given area will be counted to know the density of hair.

Photographs are also taken by a Dermoscopy device connected to cell phone at a distance of 16cm from the glabella. The thickness of five randomly selected hairs in close proximity will be measured using 3D slicer 5.8.1 software and then averaged.

After obtaining an informed consent, patients will be distributed into 2 groups A and B via randomization sequence provided by statistician.

Group A will be treated with oral minoxidil 2.5 mg OD and group B will be treated with oral dutasteride 0.5 mg OD .

All patients will be followed every month for 6 months. Macroscopic Serial photographs, dermoscopic images will be taken each month of follow up to measure hair density and thickness.

Adverse effects are enquired each month, if any will be noted.

After 6 months, Final assessment of response to treatment will be done by comparing hair thickness and density with baseline values.

Macro-Photographs will be assessed using a standardized 7-point rating scale to evaluate hair growth compared to baseline.

Patient satisfaction will be assessed using patient satisfaction score, while physician will assess the improvement via visual analogue scale and will be compared with baseline.

 
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