The aim of the present study was to formulate a topical solution of minoxidil, spironolactone, and azelaic acid and its clinical evaluation in androgenic alopecia.
Design
A randomized controlled clinical trial with a parallel group
Settings and conduct
The present study is a two-group clinical trial that will be conducted in Hamedan city in 1404 with the participation of 50 patients with androgenic alopecia. Patients will be randomly divided into two groups (an intervention group and a control group).Intervention group: They will receive a solution containing minoxidil 5%, spironolactone 5%, and azelaic acid 1.5% twice daily for three months.Control group: The patients use a solution containing minoxidil 5% in two sessions for three months.
Participants/Inclusion and exclusion criteria
Age group older than 18 years and diagnosis of androgenetic alopecia and severity of the disease and the individual by dermatologists and hair specialists, as well as the absence of other diseases
Intervention groups
Intervention group: They will receive a solution containing minoxidil 5%, spironolactone 5%, and azelaic acid 1.5% twice daily for three months.
Control group: The patients use a solution containing minoxidil 5% in two sessions for three months.
Main outcome variables
Incidence and severity of androgenetic alopecia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046143N3
Registration date:2025-10-18, 1404/07/26
Registration timing:prospective
Last update:2025-10-18, 1404/07/26
Update count:0
Registration date
2025-10-18, 1404/07/26
Registrant information
Name
Seyed Yaser Vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3426 6353
Email address
y.vafaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-22, 1404/07/30
Expected recruitment end date
2026-04-20, 1405/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and Clinical evaluation of the combined solution of minoxidil, azelaic acid and spironolactone in the treatment of androgenic alopecia
Public title
Preparation and Clinical evaluation of the combined solution of minoxidil, azelaic acid and spironolactone in the treatment of androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of androgenetic alopecia and its severity
Informed consent of the patient
No specific underlying diseases
Absence of other skin diseases
Exclusion criteria:
Sensitivity to soluble components
Diabetic patients with heart failure Pregnancy during the study Side effects that are not tolerated by the patient Immune deficiency Malignant diseases
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same in the two groups. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.
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
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Approval date
2025-10-04, 1404/07/12
Ethics committee reference number
IR.UMSHA.REC.1404.566
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
Incidence and severity of Androgenic Alopecia
Timepoint
Before and up to 3 months after the intervention
Method of measurement
World Health Organization Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive a solution containing minoxidil 5%, spironolactone 5%, and azelaic acid 1.5% twice daily for three months.
Category
Treatment - Drugs
2
Description
Control group: The patients use a solution containing minoxidil 5% in two sessions for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Farshchian Hospital
Full name of responsible person
Seyed Yaser Vafaei
Street address
Hamadan, Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 1590
Email
y.vafaei@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hanedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0717
Email
s_bashirian@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
Seyed Yaser Vafaei
Position
Assistant Prophessor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 1590
Email
y.vafaei@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Yaser Vafaei
Position
Assistant Prophessor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1590
Email
y.vafaei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Yaser Vafaei
Position
Pharmaceutics Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
ُFaculty of pharmacy, Hamadan university of medical science, Shahid Fahmideh ave, Hamadan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3426 6353
Email
y.vafaei@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