Effect of topical minoxidil combined with topical finasteride versus topical minoxidil monotherapy in male androgenetic alopecia: single-blind randomized clinical trial
Aim:
To assess the effect of topical minoxidil combined with topical finasteride versus topical minoxidil monotherapy in male androgenetic alopecia
Design
This is a Phase III single-blind randomized clinical trial with a control group with parallel groups, in which 32 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 32 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Male androgenetic alopecia,
Exclusion criteria:
History of treatment in the past 6 months,
Cardiovascular diseases
Intervention groups
Intervention group:
Topical minoxidil 5% plus topical finasteride 0.25% on alopecia location twice daily for 4 months
Control group:
Topical minoxidil 5% on alopecia location twice daily for 4 months
Main outcome variables
Primary outcome:
Average of hair concentration, Average of hair dimeter, Average of hair drop,
The rate of patient’s satisfaction
Secondary outcome:
Probable treatment side effects (redness, itching, burning)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N605
Registration date:2026-04-21, 1405/02/01
Registration timing:prospective
Last update:2026-04-21, 1405/02/01
Update count:0
Registration date
2026-04-21, 1405/02/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical minoxidil combined with topical finasteride versus topical minoxidil monotherapy in male androgenetic alopecia: single-blind randomized clinical trial
Public title
Effect of topical minoxidil combined with topical finasteride versus topical minoxidil monotherapy in male alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Male androgenetic alopecia,
Exclusion criteria:
History of treatment in the past 6 months,
Cardiovascular diseases
Age
From 18 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-12-13, 1404/09/22
Ethics committee reference number
IR.UMSHA.REC.1404.765
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Average of hair concentration
Timepoint
Before the intervention and 4 months later
Method of measurement
Through physical examination
2
Description
Average of hair dimeter
Timepoint
Before the intervention and 4 months later
Method of measurement
Through physical examination
3
Description
Average of hair drop
Timepoint
Before the intervention and 4 months later
Method of measurement
Through physical examination
4
Description
The rate of patient’s satisfaction
Timepoint
4 months after the intervention
Method of measurement
Through 5-choice question in Likert scale
Secondary outcomes
1
Description
Probable treatment side effects (redness, itching, burning)
Timepoint
4 months after the intervention
Method of measurement
Through taking history
Intervention groups
1
Description
Intervention group: Topical minoxidil 5% plus topical finasteride 0.25% on alopecia location twice daily for 4 months
Category
Treatment - Drugs
2
Description
Control group: Topical minoxidil 5% on alopecia location twice daily for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr. Alireza Ashraf Abadi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
alireza.ashrafabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Ashraf Abadi
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
alireza.ashrafabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Ebrahimi
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
b.ebrahimi.4326@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available