Comparison of the effectiveness of add combined treatment of topical minoxidil andoral finasteride and carboxytherapy with topical minoxidil and oral finasteride in men patients with moderate to severe androgenic alopecia referred to educational clinics Isfahan university of medical science
Determining the average density and thickness of hair (improvement of hair condition) in patients with moderate to severe androgenetic alopecia in groups treated with topical minoxidil and finasteride and carboxytherapy before and after treatment according to age and duration of treatment
Design
The number of 30 patients among the patients who are eligible to enter the study and have consented to participate in the study
Randomly, the numbers are numbered from 1 to 30 and these numbers are randomly placed in two equal groups, and then they are assigned to patients numbered 1 to 30 and assigned to the desired groups based on their entry.
Settings and conduct
The first group is treated with topical minoxidil and oral finasteride and the second group is treated with topical minoxidil and oral finasteride and carboxytherapy. Then hair density and hair thickness, patient satisfaction level and doctor's evaluation before starting the study and after the treatment are examined.
Participants/Inclusion and exclusion criteria
ligibility criteria:
1- Patients who are willing to participate in the study.
Criteria for not entering the study:
1- Patients suffering from other types of alopecia, such as alopecia areata, telogen effluvium, anagen effluvium and alopecia
Oscar winner
2- Patients with psoriasis or lichen planus due to the positive Kübner phenomenon in these diseases.
3- Any serious systemic diseases, including cancers, vascular collagen diseases, liver and kidney diseases, cardiovascular and thyroid diseases.
Intervention groups
In the intervention group, the therapeutic effect of carboxytherapy along with standard treatment and in the control group, the effect of standard androgenic hair loss treatment is evaluated.
Main outcome variables
The effect of carboxytherapy adjuvant treatment is determined along with the standard treatment of androgenic alopecia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241005063265N1
Registration date:2024-10-09, 1403/07/18
Registration timing:registered_while_recruiting
Last update:2024-10-09, 1403/07/18
Update count:0
Registration date
2024-10-09, 1403/07/18
Registrant information
Name
Hamzeh Shafiei najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 4024
Email address
hamzeh.najafi.1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of add combined treatment of topical minoxidil andoral finasteride and carboxytherapy with topical minoxidil and oral finasteride in men patients with moderate to severe androgenic alopecia referred to educational clinics Isfahan university of medical science
Public title
Investigating the effect of carboxytherapy on hormonal hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are willing to participate in the study
Exclusion criteria:
_Patients suffering from other types of alopecia such as alopecia areata, telogen effluvium, anagen effluvium and alopeciaOscar winner2- Patients with psoriasis or lichen planus due to the positive Kübner phenomenon in these diseases.3- Any serious systemic diseases, including cancers, vascular collagen diseases, liver and kidney diseases, cardiovascular and thyroid diseases.4- Patients who have done hair transplant in the past
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 30 patients among the patients who are eligible to enter the study and have consented to participate in the study
Randomly, the numbers are numbered from 1 to 30 and these numbers are randomly placed in two equal groups, and then they are assigned to patients numbered 1 to 30 and assigned to the desired groups based on their entry
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Shiraz Gate, Hazar Jarib Street, Kharazi Hostel
City
Isfahan
Province
Isfehan
Postal code
8174673516
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.MUI.MED.REC.1403.056
Health conditions studied
1
Description of health condition studied
Androgenic hair loss
ICD-10 code
XII
ICD-10 code description
XII Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
Density and thickness of hair
Timepoint
The beginning of the study and the 3rd and 6th months of the study
Method of measurement
HANDY SCOPE FOTOFINDER Dermatoscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the group that receives standard treatment along with carboxytherapy
Category
Treatment - Surgery
2
Description
Control group: The group receiving only standard treatment including minoxidil solution and finasteride tablets
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hamzeh Shafiei
Street address
Shiraz Gate, Hazarjerib Street, Kharazi Hostel
City
Isfahan
Province
Isfehan
Postal code
8174673516
Phone
+98 66 3322 4024
Email
Hamzeh.najafi.1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research assistant
Street address
Gate of Shiraz, Hazarjerib, Khorazi dormitory
City
Isfahan
Province
Isfehan
Postal code
8174673516
Phone
+98 916 544 8517
Email
Hamzeh.najafi.1373@gmail.com
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
Hamzeh Shafiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Gate of Shiraz, Hazarjerib, Kharazi Hostel
City
Isfahan
Province
Isfehan
Postal code
8174673516
Phone
+98 66 3322 4024
Email
Hamzeh.najafi.1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamzeh Shafiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Gate of Shiraz, Hazarjerib, Khorazi dormitory
City
Isfahan
Province
Isfehan
Postal code
8174673516
Phone
+98 66 3322 4024
Email
Hamzeh.najafi.1373@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamzeh Shafiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Gate of Shiraz, Hazarjerib, Khorazi dormitory
City
Isfahan
Province
Isfehan
Postal code
8174673516
Phone
+98 66 3322 4024
Email
Hamzeh.najafi.1373@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information related to the outcome of the study, such as the density and thickness of the hairs and the treatment response, is published
When the data will become available and for how long
About 3 months after printing the resultsم
To whom data/document is available
Researchers and medical students
Under which criteria data/document could be used
If a researcher or student wants to conduct new studies on a related topic
From where data/document is obtainable
To the registrar of the study whose information was told
What processes are involved for a request to access data/document
Contact the registrar or message the registrar and send the zip code and then send the information via email or post