Evaluation of the effect of oral finasteride in comparison with oral dutasteride in treatment of male androgenetic alopecia.
Design
Community based, parallel group, single blind, randomized trial, phase 3 on 80 patients. Random allocation software is used for randomization.
Settings and conduct
In this study, 80 male patients with moderate to severe androgenetic alopecia referred to medical centers of Isfahan University of Medical Sciences are enrolled after completing a thorough explanation of the course and purpose of the study, as well as physical examination, complete history of the disease and obtaining informed consent. Patients are randomly assigned to two groups. The first group receives oral finasteride 1 mg/day and the second group receives oral dutasteride 0.5 mg/day. After 25 weeks of treatment, patients are compared and evaluated by standard photography and trichogram obtained at the beginning and end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male patients diagnosed with moderate to severe androgenetic alopecia who do not have any of the followings (Non-inclusion criteria): any serious systemic disease, psoriasis or lichen planus; other types of alopecia; any andrological condition known to affect semen parameters and male fertility; history of hair transplant; history of breast cancer or male infertility in first degree relatives; received any treatment for alopecia in the past three months.
Exclusion criteria: Serum levels of prostate specific antigen (PSA) greater than 2 ng/ml; Abnormal liver function tests (except chronic stable hepatitis B and C).
Intervention groups
Intervention group 1: These patients receive oral finasteride 1 mg per day.
Intervention group 2: These patients receive oral dutasteride 0.5 mg per day.
Main outcome variables
Hair thickness; number of hair; change of photographic score; patient satisfaction score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231025059850N1
Registration date:2024-01-27, 1402/11/07
Registration timing:registered_while_recruiting
Last update:2024-01-27, 1402/11/07
Update count:0
Registration date
2024-01-27, 1402/11/07
Registrant information
Name
reza makhmali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3329 7212
Email address
rezamakhmali2014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy and safety of oral finasteride with oral dutasteride in moderate to severe male androgenetic alopecia
Public title
Comparing The Effect of Finasteride With Dutasteride on Hair Growth in Male Androgenetic Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients diagnosed with moderate to severe androgenetic alopecia (grade 3, 4, 5 Hamilton-norwood scale)
Do not have any of the followings (Non-inclusion criteria): any serious systemic disease, psoriasis or lichen planus; other types of alopecia (including anagen effluvium, telogen effluvium and scarring alopecia); any andrological condition known to affect semen parameters and male fertility (including varicocele, cryptorchidism, testicular cancer, testicular trauma, orchitis, urinary tract infection; previous chemotherapy or radiotherapy); history of hair transplant; history of breast cancer or male infertility in first degree relatives.
Patients who have not received any treatment for alopecia in the past three months
Exclusion criteria:
Serum levels of prostate specific antigen (PSA) greater than 2 ng/ml
Abnormal liver function tests (except chronic stable hepatitis B and C)
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Our study is single blinded in which the type of drug administered is unclear to investigator.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-20, 1402/07/28
Ethics committee reference number
IR.MUI.MED.REC.1402.177
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Number of hair follicles
Timepoint
Obtaining standard photographic pictures before the intervention and 25 weeks after the intervention
Method of measurement
A 7-point questionnaire developed by a physician based on the comparison of standard photographic pictures (checking the thickness and number of hairs).
2
Description
Hair growth rate
Timepoint
perform scalp dermoscopy before the intervention and 25 weeks after the intervention
Method of measurement
A 7-point questionnaire developed by a physician based on the comparison of phototrichograms (checking the thickness and number of hairs).
3
Description
Patient satisfaction score
Timepoint
before the intervention and 25 weeks after the intervention which is the end of the study
Method of measurement
مقیاس آنالوگ بصری
Secondary outcomes
1
Description
Sexual dysfunction
Timepoint
Before the intervention and 25 weeks after the intervention which is the end of the study
Method of measurement
Interview with the patient
2
Description
Erectile dysfunction
Timepoint
Before the intervention and 25 weeks after the intervention which is the end of the study
Method of measurement
Interview with the patient
3
Description
Any side effects following consumption of finasteride and dutasteride
Timepoint
Every 3 months
Method of measurement
Interview with the patient
Intervention groups
1
Description
Intervention group 1: Oral consumption of finasteride 1 mg daily for 25 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral consumption of dutasteride 0.5 mg daily for 25 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dermatology clinic, Al-Zahra University Hospital
Full name of responsible person
Nazila Poostiyan
Street address
Soffe Blvd
City
Esfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
n.poostiyan@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Sedighe Tahereh Comprehensive Medical and Rehabilitation Center, Skin Disease Research Center
Full name of responsible person
Nazila Poostiyan
Street address
Khoram St.
City
Esfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3337 3736
Email
n.poostiyan@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
No.4 building., Esfahan University of Medical Sciences., Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
vcr-office@med.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
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
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Poostiyan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology Department, Al-Zahra Hospital, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
N.poostiyan@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila poostiyan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology Department, Al-Zahra Hospital, Hezar Jerib St.