A comparative study of the efficacy and side effects of using oral minoxidil versus topical minoxidil in male pattern androgenetic alopecia patients referring to razi hospital 1401-1402.
Studying the efficacy and side effects of oral minoxidil on male patern androgenetic alopecia incomparison with topical minoxidil .
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 50 patients. Patients are randomly assigned to one of two groups based on block randomization.
Settings and conduct
Before treatment, the least hair density areas in the frontal, vertex and temporal parts of the scalp are marked by tattoo material by a dermatologist. Before, during and after the treatment , the number of hairs in the same area is measured using a trichoscope. Calculation and comparing is done by taking pictures . The area of minimum density is selected. During the research period, the participants, every month for 3 months and then 6 months after the start of the treatment, in terms of biometric parameters are examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age above 18 years
• AGA patients based on clinical examination and trichoscopy
• male gender
• Patients with grade 3 to 5 according to Hamilton's classification for male pattern hair loss
Exclusion criteria:
• Another treatments for hair loss in the last 3 months
• Alcohol and drug use
• High blood pressure
•Heart disease
• Allergy to study drugs
• Severe liver and kidney diseases
• Simultaneous use of other AGA treatments
Intervention groups
Case group:
Using oral minoxidil at a dose of 2.5 mg to a maximum dose of 5 mg daily .
control group:
Using topical minoxidil on the scalp area .
Main outcome variables
The positive effect of low dose oral minoxidil on male pattern androgenetic alopecia with no complications .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221101056366N1
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Elham Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3334 3157
Email address
e.yousefi.y@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the efficacy and side effects of using oral minoxidil versus topical minoxidil in male pattern androgenetic alopecia patients referring to razi hospital 1401-1402.
Public title
Studying the effecf of oral minoxidil on androgenetic hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
AGA patients based on clinical examination and trichoscopy
Male gender
Patients with grade3 to 5 according to Hamilton's classification for male pattern hair loss
Exclusion criteria:
Another treatments for hair loss in the last 3 months
Alcohol and drug use
High blood pressure
Heart disease
Allergy to study drugs
Severe liver and kidney diseases
Simultaneous use of other AGA treatments
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was used in this study . In this method simple randomization models like tossing a coin , using randomized number tables, or computerized methods of randomization is used . In this method each case is allocated in one group ( control or intervention) by tossing a coin for example.Some advantages of this method are unpredictability of treatment used for each case.Implementing of this method is simple..
Blinding (investigator's opinion)
Single blinded
Blinding description
After entering the study, the participants do not know whether they are in the case or control group, but the doctor does
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
No. 72, block B, unit 6, corner of Sabrian alley, Esfandani street, Tehranpars
City
Tehran
Province
Tehran
Postal code
1654885981
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.410
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
Total hair density, hair thickness,and the total number of vellus and terminal hairs
Timepoint
before the start of the study and 1, 2, 3 ,6 months after the start of the study
Method of measurement
Using digital video trichoscope and photography
Secondary outcomes
1
Description
Total hair density per centimeter square, hair thickness, number of hairs per follicular unit and patient's quality of life based on DLQI
Timepoint
1, 2, 3 ,6 months after the initiation of the study
Method of measurement
Using a digital video trichoscope
Intervention groups
1
Description
Intervention group: 2.5 mg minoxidil tablets, once daily and gradually increasing the dose to twice daily for six months orally
Category
Treatment - Drugs
2
Description
Control group: 5% minoxidil solution once a day for six months topically
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Elham yousefi
Street address
No. 72, Block B, Unit 6, Esfandani Street, TehranPars
City
Tehran
Province
Tehran
Postal code
1654885981
Phone
+98 939 546 2948
Email
e.yousefi.y@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam nasimi
Street address
Tehran University of Medical Sciences, Revolution Square, Porsina St
City
Tehran
Province
Tehran
Postal code
1654885981
Phone
+98 912 843 5986
Email
nsm.maryam@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
Elham yousefi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 72, Block B, Unit 6, Esfandani Street, Tehran Pars
City
Tehran
Province
Tehran
Postal code
1654885981
Phone
+98 939 246 2948
Email
e.yousefi.y@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam nasimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Porsina Street, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
26542542214
Phone
+98 912 843 5986
Email
nsm.maryam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam nasimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Porsina Street, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
26542542214
Phone
+98 912 843 5986
Email
nsm.maryam@gmail.com
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