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CTRI Number  CTRI/2024/08/071840 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing effectiveness of topical minoxidil versus topical minoxidil with dutasteride injections in male patients with male pattern hair loss 
Scientific Title of Study   Comparative study of topical minoxidil versus topical minoxidil with dutasteride mesotherapy in androgenetic alopecia A one year hospital based randomized control trial at tertiary care hospital 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenal Agrawal  
Designation  Junior resident  
Affiliation  Jawaharlal Nehru medical college,KLE university  
Address  Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8839619313  
Fax    
Email  Minalagrawal.sn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivakumar K Patil 
Designation  Associate Professor  
Affiliation  Jawaharlal Nehru medical college,KLE university  
Address  Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9844512315  
Fax    
Email  shivakumarkpatil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivakumar K Patil 
Designation  Associate Professor  
Affiliation  Jawaharlal Nehru medical college,KLE university  
Address  Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9844512315  
Fax    
Email  shivakumarkpatil@gmail.com  
 
Source of Monetary or Material Support  
2nd floor, Skin OPD 23, Dr Prabhakar kore hospital,Jawaharlal Nehru medical college, Belgaum, Karnataka,590010 
 
Primary Sponsor  
Name  Dr. Meenal Agrawal  
Address  Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka  
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 Meenal Agrawal   KLE,Dr Prabhakar kore hospital,Belgaum   2nd floor, Skin OPD 23, Room number 2
Belgaum
KARNATAKA 
8839619313

Minalagrawal.sn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC institutional ethics committee  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 
Intervention  Dutasteride with topical minoxidil   Mesotherapy with dutasteride will be done once monthly and topical minoxidil to be used 1ml twice daily  
Comparator Agent  Topical minoxidil   This solution will be given to apply 1ml twice daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Patient with Androgenetic Alopecia confirmed by clinical correlation and trichoscopy.
Male Patients belonging to age group of 18-55 years.
Patients of Norwood classification grading III,IV,V.
Patients with no known comorbidites 
 
ExclusionCriteria 
Details  Norwood classification grading III, VI, VII.
Patients with other forms of alopecia
Patients with dermatological or systemic illness known to cause diffuse hair loss
Patients who received PRP or any hair growth promoters in the past six months
Patients who underwent surgical hair transplantation.
Patients on hormonal, androgenic or anti androgenic medications, cytotoxic, and inhibitors of
CYP3A4
Patients suffering from decreased libido, ejaculatory or erectile dysfunction
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increased hair density observed trichoscopically  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced inter follicular distance observed trichoscopically  4 months 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   30/08/2024 
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="1"
Months="0"
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  

Although Androgenetic alopecia is often regarded as a rather minor dermatological condition, it affects one’s self-esteem and can be a major source of anxiety and depression for some men.Even while practicing dermatologists and hair specialists deal with it frequently, it might be one of the most difficult conditions to cure because choosing a course of therapy frequently requires careful evaluation of many different aspects as well as ethical decision‐making. The most crucial elements to take into account are treatment cost, practicality in terms of promoting compliance, side effect profiles, and effectiveness—especially in light of the chronic nature of the disease.

While hair transplant surgery is an expensive alternative that may not always provide good results requiring numerous procedures to obtain the necessary hair density, medical treatment for AGA may not be suited for all people and may take a long time to show benefits. Therefore, if mesotherapy with dutasteride turns out to be as effective and safe as the current treatment, it might be a tempting substitute.

 
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