| CTRI Number |
CTRI/2025/11/097307 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [platelet rich plasma therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Oral and Topical Minoxidil with PRP for Treating Male Pattern Baldness |
|
Scientific Title of Study
|
A Comparative Study between Oral Administration of 2.5 mg Minoxidil and Topical Application of 5 percent Minoxidil in Conjunction with Autologous Platelet-Rich Plasma for the Treatment of Male 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 |
Lamiya Latheef Rawther |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology,Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe),Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9384840470 |
| Fax |
|
| Email |
lamiyalatheefrawther@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adarsh Lata Singh |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology,Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe),Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765404086 |
| Fax |
|
| Email |
alsingh1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lamiya Latheef Rawther |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology,Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe),Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9384840470 |
| Fax |
|
| Email |
lamiyalatheefrawther@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lamiya Latheef Rawther |
Acharya Vinoba Bhave Rural Hospital |
Department of Dermatology,Venereology and Leprosy,Block E, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
09384840470
lamiyalatheefrawther@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No placebo group |
No placebo group. This is a comparative study, with PRP being common in both groups. And that we are assessing efficacy of oral vs topical Minoxidil without a control group |
| Intervention |
Oral Administration of 2.5 mg Minoxidil and Topical Application of 5% Minoxidil |
Oral Administration of 2.5 mg Minoxidil in group A and Topical Application of 5% Minoxidil in group B with Conjunction of Autologous Platelet Rich Plasma as an adjunct therapy in both the groups for the Treatment of Male Androgenetic Alopecia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Male patients aged 18 to 50 years
2.Clinically diagnosed of patients of AGA classified according to Hamilton Norwood stage II to V
3.No treatment taken for hair loss topical, oral or procedural in the past 1 month.
4.Willing to provide informed consent to comply with all aspects of the study protocol.
|
|
| ExclusionCriteria |
| Details |
1.Patients with scarring alopecia or other forms of hair loss e.g. alopecia areata, telogen effluvium.
2.Patients who are a known case of Coagulopathies or on anticoagulant,antiplatelet therapies.
3.Active scalp infections or any scalp dermatoses.
4.Use of immunosuppressive or hormonal therapies.
5.Severe co morbidities like Cardiovascular or endocrine disorders ,uncontrolled diabetes, renal or hepatic disorders.
6.Known hypersensitivity to minoxidil or PRP constituents.
7.Seropositivity for HIV, Hepatitis B, or Hepatitis C
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the hair shaft diameter and Hair density in both groups ,will be assessed at baseline and every 4 weekly using Tricoscopy. |
Assessment will be done in 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the patient satisfaction by using a standardized 5 point Likert scale . |
Assessment will be done in 4 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/12/2025 |
| 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="2"
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
|
Background
Androgenetic alopecia is a prevalent , non scarring form of progressive hair loss in men, affecting upto 80% by age 70 . FDA approved treatments , including topical minoxidil and oral finasteride are limited by suboptimal efficacy , side effects and poor compliance . Low dose oral minoxidil and autologous PRP therapy have recently emerged as promising alternative.
Objective
To compare the efficacy , safety and early response rates of oral minoxidil 2.5 mg with PRP versus topical 5 % minoxidil with PRP in male AGA patients.
Methodology
A prospective, randomised , comparative , interventional study will be conducted over a span of two years at AVBRH Wardha , involving 50 male patients via Hamilton norwood grading of II to V , divided equally in two groups . Group A will receive oral minoxidil 2.5 mg daily along with monthly PRP, while Group B will receive topical 5 % minoxidil twice daily along with monthly PRP. Efficacy will be assessed at baselines and 4 weeks interval over 12 weeks via trichoscopy, clinical photographs and patient satisfaction using a 5 point likert scale .
Conclusion
This study aims to generate comparative data on oral versus topical minoxidil in conjunction with PRP and to identify early therapeutic responders for more personalised and effective AGA mangement. |