Comparing the efficacy and safety of the combination of minoxidil 2.5 mg dutasteride 0.5 mg with minoxidil 2.5 mg and dutasteride 0.5 mg alone in the treatment of androgenic alopecia in men
The main aims of the project:
Comparison of the effectiveness of combined treatment with oral minoxidil 2.5 mg and dutasteride 0.5 mg with each drug alone in men with androgenic alopecia.
Design
Parallel-group, single-blind, randomized, phase 3 clinical trial without control group on 45 patients. Random allocation software was used for randomization.
Settings and conduct
This study is conducted at the Research Center for Skin Diseases and Leprosy. Images of the vertex area are recorded in all patients with a camera and a dermoscope at the beginning of the intervention and 2 months, 4 months and 6 months later. Examination of the images prepared by two dermatologists that the changes in the number and density of the hair are compared. The people who evaluate the data don't know what treatment the patient has received.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years with male androgenetic alopecia grade 2 to 4 vertex of Norwood-Hamilton classification who have not received any other medical treatment for hair loss in the last 6 months.
Exclusion criteria:
Patients who are being treated with other drugs, and patients with grade I of androgenic alopecia and patients with severe complications after taking drugs are excluded from the study. Liver and TSH tests (tests in the last 6 months can be it is accepted) it is requested that they will be excluded from the study in case of disorder. Patients with prostate and breast cancer in the last 5 years will be excluded from the study.
Intervention groups
First intervention group, 2.5 mg minoxidil capsules are taken orally for 6 months.
Second intervention group, 0.5 mg dutasteride capsules are taken orally for 6 months.
Third intervention group, a combined capsule of minoxidil 2.5 mg and dutasteride 0.5 mg is taken orally for 6 months.
Main outcome variables
Changes in the number and density of hair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240304061159N1
Registration date:2024-04-30, 1403/02/11
Registration timing:registered_while_recruiting
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
sina babakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
babakhanisina1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-27, 1403/02/08
Expected recruitment end date
2024-10-29, 1403/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy and safety of the combination of minoxidil 2.5 mg dutasteride 0.5 mg with minoxidil 2.5 mg and dutasteride 0.5 mg alone in the treatment of androgenic alopecia in men
Public title
Comparing the efficacy and safety of the combination of minoxidil 2.5 mg dutasteride 0.5 mg with minoxidil 2.5 mg and dutasteride 0.5 mg alone in the treatment of androgenic alopecia in men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years with male androgenetic alopecia grade 2 to 4 vertex of Norwood-Hamilton classification who have not received any other medical treatment for hair loss in the last 6 months
Exclusion criteria:
Patients who are not diagnosed with androgenic alopecia or are being treated with other drugs, and patients with grade I of androgenic alopecia and patients with severe complications after taking drugs are excluded from the study. Liver and TSH tests (tests in the last 6 months can be it is accepted) it is requested that they will be excluded from the study in case of disorder. Patients with a history of hair transplantation and patients with prostate and breast cancer in the last 5 years will be excluded from the study. patients with a history of diseases related to the right ventricle and neurogenic hypotension And spinal injuries are not included in the study.
Age
From 18 years old to 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into three separate groups by random allocation software
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor and data analyst are unaware of the intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.173
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
Counting the number and density of hair with Trichoscan
Timepoint
Before the start of the study and 2,4,6 months after the start of the intervention
Method of measurement
Trichoscan
Secondary outcomes
1
Description
Comparison of hair changes and hair growth with photography
Timepoint
Before the start of the study and 2,4,6 months after the start of the intervention
Method of measurement
Photographic Examination
Intervention groups
1
Description
Intervention group: In the first group, one third of the patients, which are estimated to be 15, are treated with 2.5 mg oral minoxidil tablets, 1 tablet per day for a period of 6 months, which is given to them in the form of packages of 60 tablets for two months. The tablets are given by the Center of Research and Training on skin diseases and leprosy has been processed.
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, one third of the patients, which are estimated to be 15, are treated with 0.5 mg oral dutasteride tablets, 1 tablet per day for a period of 6 months, which is given to them in the form of packages of 60 tablets for two months. The tablets are given by the Center of Research and Training on skin diseases and leprosy has been processed.
Category
Treatment - Drugs
3
Description
Intervention group: In the third group, one third of the patients, which are estimated to be 15, are treated with combined tablets of 0.5 mg of oral dutasteride and 2.5 mg of oral minoxidil, 1 tablet per day for a period of 6 months, which is given to them in the form of 60 tablets for two months. The tablets are given by the Center of Research and Training on skin diseases and leprosy has been processed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Research and Training on skin diseases and leprosy
Full name of responsible person
Sina Babakhani
Street address
No. 415 , Naderi intersection , Taleghani St. , Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
babakhanisina1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali akbari sari
Street address
No. 415 , Naderi Intersection , Taleghani Street , Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
babakhanisina1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Intersection, Taleghani Street, Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
babakhanisina1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Intersection, Taleghani Street, Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
babakhanisina1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sina Babakhani
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Intersection, Taleghani Street, Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
babakhanisina1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Everyone
Under which criteria data/document could be used
No limitations
From where data/document is obtainable
Dr. Sina Babakhani/ 00989182364825
What processes are involved for a request to access data/document
By phone, the data will send up to two weeks later