| 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
|
|
|
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
|
|
|
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. |