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CTRI Number  CTRI/2024/03/063787 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Assessment of the low dose oral minoxidil in the post hair transplant treatment 
Scientific Title of Study   Evaluating the efficacy of low dose oral minoxidil Post Hair Transplant, in patterned hair loss: A Prospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS (23-24)-011, Version:1 dated:16 Nov 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha C 
Designation  Consultant Dermatologist and HOD.of Trichologist  
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Trichology Room No 19 5/1,4th Main MRCR Layout Vijayanagar
5/1,4th Main MRCR Layout Vijayanagar
Bangalore
KARNATAKA
560040
India 
Phone  8095196167  
Fax    
Email  drmeghacs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Megha C 
Designation  Consultant Dermatologist and HOD.of Trichologist  
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Trichology Room No 19 5/1,4th Main MRCR Layout Vijayanagar
5/1,4th Main MRCR Layout Vijayanagar
Bangalore
KARNATAKA
560040
India 
Phone  8095196167  
Fax    
Email  drmeghacs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Megha C 
Designation  Consultant Dermatologist and HOD.of Trichologist  
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Trichology Room No 19 5/1,4th Main MRCR Layout Vijayanagar
5/1,4th Main MRCR Layout Vijayanagar
Bangalore
KARNATAKA
560040
India 
Phone  8095196167  
Fax    
Email  drmeghacs@gmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciences 5/1,4th Main MRCR Layout Vijayanagar Bangalore 560040 
 
Primary Sponsor  
Name  NA 
Address  NIL 
Type of Sponsor  Other [NA] 
 
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 Megha C  CUTIS Academy of Cutaneous Sciences  Department of Trichology Room No 19 5/1,4th Main MRCR Layout Vijayanagar 5/1,4th Main MRCR Layout Vijayanagar
Bangalore
KARNATAKA 
8095196167

drmeghacs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CUTIS 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 
Comparator Agent  NA  NA 
Intervention  Oral Minoxidil: 0.25mg followed by 0.5mg tab  First week 0.25-tab followed by 0.5 tab for a week followed by 1 tab for a week and continue to 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All male patients who undergo hair transplantation following no response to conventional therapies
Patient consenting for study  
 
ExclusionCriteria 
Details  Patient with history of cardio vascular diseases
Patients with chronic renal diseases
Patient with history of hypotension
Patient taking medications like aspirin, blood thinners and guanethidine 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of oral minoxidil in post hair transplantation patients.
To assess the safety and adverse effects associated low dose oral minoxidil.
To evaluate patient satisfaction and subjective perceptions of treatment outcome. 
After 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy will be evaluated by hair counts, hair diameter measurements, anagen telogen ratio photographic assessment by trichoscan  After 6 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial
Modification(s)  
Phase 4 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 08/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Androgenetic alopecia (AGA), colloquially known as male or female pattern baldness, is a hereditary condition characterized by progressive hair thinning and loss. It is the most common cause of hair loss, affecting both men and women. AGA results from a complex interplay of genetic and hormonal factors, particularly the influence of androgens like dihydrotestosterone (DHT) on susceptible hair follicles. The psychological impact of AGA can be profound, affecting self-esteem and quality of life. While not curable, various treatments, including topical minoxidil, oral finasteride, and hair transplantation, aim to slow progression or restore hair density (1)

Hair transplantation (HT) is a method of transferring hair follicles from a donor area to a recipient/bald area. The most commonly chosen donor site is the occipital region as the hair in this region is unaffected by AGA. When the hair in the occipital region is scanty or insufficient, facial hair and body hair may be used. The rationale for hair transplantation in AGA is donor dominance, i.e., the transplanted hair continues to be unaffected by the balding process even after relocation to the new site (2). Hair transplantation is a widely adopted solution for androgenetic alopecia, yet postoperative challenges persist, such as delayed growth and donor site scarring.

This research investigates the potential of oral minoxidil in enhancing post-transplantation outcomes. Recognizing the need for adjunctive therapies, we explore the rationale behind incorporating oral minoxidil, initially a vasodilator, and its impact on graft survival, growth acceleration, and overall patient satisfaction.

Minoxidil is the only other drug that is approved by the USFDA for the treatment of AGA. After conversion to its active form, i.e., minoxidil sulphate, it acts on the receptors on arterial smooth muscle cells to cause vasodilatation. This leads to a prolonged anagen of the miniaturized hair follicle and reduced shedding  
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