Protocol summary

Study aim
The aim of this study is to compare the efficacy of combined therapy with minoxidil and platelet-rich plasma (PRP) versus conventional minoxidil monotherapy in patients with androgenetic alopecia referred to Al-Zahra Hospital in Isfahan
Design
This study is a randomized, two-arm, parallel-group, superiority, single-center clinical trial. Eligible patients were randomly allocated into either a combined treatment group (minoxidil + PRP) or a conventional treatment group (minoxidil alone) using a random number table. The sample size was determined based on the study inclusion and exclusion criteria, and outcome assessments were performed uniformly in both groups.
Settings and conduct
The study isconducted at Al-Zahra Hospital in Isfahan, in the dermatology outpatient clinic. Eligible patients are enrolled after obtaining informed consent and are randomly assigned to one of the two treatment groups. All treatment procedures and follow-up assessments are performed under the supervision of a dermatologist.
Participants/Inclusion and exclusion criteria
Patient consent Diagnosis confirmed by a specialist physician Age between 18 and 45 years No pharmacological treatment for alopecia within the past 6 months No history of cardiovascular disease and no use of antihypertensive medications No other types of alopecia or any systemic dermatologic disease No pregnancy, breastfeeding, or menopause in female participants
Intervention groups
The intervention group consists of patients with androgenetic alopecia who receive combined treatment with topical minoxidil and platelet-rich plasma (PRP) injections according to the study protocol
Main outcome variables
hair density, hair thickness, patient satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251231068515N1
Registration date: 2026-05-13, 1405/02/23
Registration timing: prospective

Last update: 2026-05-13, 1405/02/23
Update count: 0
Registration date
2026-05-13, 1405/02/23
Registrant information
Name
Ali Talaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0042
Email address
alitalaei14@edc.mui.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-06-20, 1405/03/30
Expected recruitment end date
2026-07-21, 1405/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of 5% minoxidil and platelet-rich plasma combination with 5% minoxidil solution in androgenetic alopecia.
Public title
Comparing the effect of 5% minoxidil and platelet-rich plasma combination with 5% minoxidil solution in androgenetic alopecia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent Diagnosis confirmed by a specialist physician Age between 18 and 45 years No history of cardiovascular disease and no use of antihypertensive medications No other types of alopecia or any systemic dermatologic disease No pregnancy, breastfeeding, or menopause in female participants No pharmacological treatment for alopecia within the past 6 months
Exclusion criteria:
Development of adverse reactions or hypersensitivity to the treatment Lack of participant compliance or withdrawal from the study for any reason
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients meeting the inclusion criteria will be randomly allocated into two intervention groups using a random number table before initiation of treatment: Group 1: Combined therapy with PRP + 5% minoxidil Group 2: Monotherapy with 5% minoxidil Participants will remain unaware of their group assignment until the start of the intervention, ensuring initial patient blinding until treatment commencement. Allocation will be performed at a 1:1 ratio without stratification, with each patient having an equal probability of assignment to either group. Note: Given the nature of the intervention (PRP injection), complete patient blinding throughout the study is not feasible. However, outcome assessment (trichoscopy and photography) will be performed by an evaluator blinded to group allocation to minimize bias.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
hezar jerib Ave
City
isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2025-12-29, 1404/10/08
Ethics committee reference number
IR.MUI.MED.REC.1404.398

Health conditions studied

1

Description of health condition studied
androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia

Primary outcomes

1

Description
hair density
Timepoint
before intervention, 6 month after intervention
Method of measurement
trichometer device

2

Description
hair thickness
Timepoint
before intervention, 6 month after intervention
Method of measurement
terichometer device

3

Description
patient satisfaction
Timepoint
6 month after intervention
Method of measurement
Patient satisfaction score with treatment: (based on a 7-point scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: platelet rich plasma, administrated two times with 3 month interval via intradermal scalp injections by a dermatologist under sterile conditions AND topical minoxidil 5%, about 1ml administrated on scalp skin two times per day for 3 months
Category
Treatment - Drugs

2

Description
Control group: topical minoxidil 5%, about 1ml administrated on scalp skin two times per day for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Ali Talaei
Street address
Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
7573181746
Phone
+98 903 542 5279
Email
alitalaei14@edc.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
7573181746
Phone
+98 31 3822 0000
Email
iraji@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
7573181746
Phone
+98 31 3822 0000
Email
iraji@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Talaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dermatology
Street address
Isfahan university of medical science, Hezar Jerib blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0042
Fax
Email
alitalaei14@edc.mui.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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