Comparison of therapeutic effects of 5% minoxidil solution alone with the combination of 5% minoxidil and flutamide solution in patients with androgenic alopecia
Comparison of therapeutic effects of minoxidil solution alone with the combination of minoxidil and flutamide solution in patients with androgenetic alopecia
Design
A randomized double-blinding clinical trial, with the parallel groups
Settings and conduct
In this study, 40 patients with androgenic alopecia will be included and will be randomly divided into two groups. Minoxidil solution will be used in one group and flutamide and minoxidil solution in the other group. Then the severity of hair loss and hair density of patients are evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria included the diagnosis of androgenic alopecia by two experienced dermatologists based on Hamilton diagnostic criteria, severity of hair loss in stages 2 to 5 according to Hamilton scale and in stages 1 and 2 according to Ludwig scale, hair loss less than 10 years and patient satisfaction to participate in the study. Exclusion criteria include a history or observation of allergies to any of the minoxidil and flutamide drugs, a history of heart disease and taking antihypertensive drugs, receiving systemic treatment for androgenic alopecia during the 6 months prior to the study, and other types of alopecia, such as Alopecia areata, telogen effluvium, anagen effluvium, and scarring alopecia and any systemic skin disease, and being pregnant or lactating, or postmenopausal women.
Intervention groups
n this study, patients in the first intervention group will receive 1 cc (equivalent to 20 drops) of 5% minoxidil solution twice a day and patients in the second intervention group will receive 1 cc (equivalent to 20 drops) of 2% flutamide + 5% minoxidil solution twice a day. Patients in both groups will take the solutions for 9 months.
Main outcome variables
Hair density; Severity of hair loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N6
Registration date:2020-10-07, 1399/07/16
Registration timing:prospective
Last update:2020-10-07, 1399/07/16
Update count:0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of 5% minoxidil solution alone with the combination of 5% minoxidil and flutamide solution in patients with androgenic alopecia
Public title
Comparison of the therapeutic effects of minoxidil solution alone with the combination of minoxidil and flutamide solution in patients with androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of androgenic alopecia by two experienced dermatologists based on Hamilton diagnostic criteria
Patient consent to participate in the study
The intensity of hair loss in stage 2 to 5 according to Hamilton scale and in stages 1 and 2 according to Ludwig scale
The duration of hair loss is less than 10 years
Exclusion criteria:
History or observation of allergies to any of the drugs minoxidil and flutamide
History of heart disease and use of antihypertensive drugs
Receiving systemic treatment for androgenic alopecia during the 6 months prior to the study
Other types of alopecia such as alopecia areata, telogen effluvium, anagen effluvium and scarring alopecia of any systemic cutaneous disease
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The two solutions of minoxidil and the combined solution of flutamide and minoxidil are already prepared by the pharmacist in the same volume and with the same color and shape, and are labeled A and B and will be given to the patients. Therefore, the patient and the researcher will not have any information about the two prescribed solutions.
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
Hezar Jarib Ave, Azadi Square.
City
Isfaha
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
IR.MUI.MED.REC.1398.562
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Hair density
Timepoint
Pre-and post-intervention
Method of measurement
Hair polarizer
2
Description
Severity of hair loss
Timepoint
Pre-and post-intervention
Method of measurement
By a skilled physician based on Hamilton-Norwood scale for male pattern hair loss and Ludwig scale for female pattern hair loss
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the first intervention group will take 1 cc (equivalent to 20 drops) of 5% minoxidil solution twice a day for 9 months.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in the second intervention group will take 1 cc (equivalent to 20 drops) of the combined solution of 2% flutamide and 5% minoxidil twice a day for 9 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Gita Faghihi
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
g_faghighi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Gita Faghihi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology Department, Al-Zahra Hospital, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
g_faghighi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gita Faghihi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology Department, Al-Zahra Hospital, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
g_faghighi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Sadat Hosseini
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Robat Street
City
Isfahan
Province
Isfehan
Postal code
8139946553
Phone
+98 31 3442 7529
Email
maedeh.hosseini71@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD