Comparison of the therapeutic effects of 5% Minoxidil solution alone with 5% Minoxidil solution and 0.005% Latanoprost in men with androgenetic alopecia
Determining and comparing the therapeutic effects of minoxidil solution alone with the combined solution of minoxidil and latanoprost in patients with androgenetic alopecia
Design
Clinical trial, with parallel, double-blind, randomized groups
Settings and conduct
50 patients referred to the dermatology clinic of Al-Zahra Hospital in Isfahan, after confirming the conditions for admission to the study and fully explaining the process and purpose of the study, and completing informed moral consent, are individually and randomly divided into two groups. this is a double-blinded study and the participants and the evaluator are unaware of the type of drug used for each person. Subjects are randomly divided into two treatment groups: Minoxidil 5%, Latanoprost 0.005% and Minoxidil 5%.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The diagnosis of androgenic alopecia based on Hamilton diagnostic criteria, the severity of hair loss 2 to 5 according to Hamilton criteria and stages 1 and 2 according to Ludwig scale and patient satisfaction to participate in the study. Exclusion criteria: having a history or observation of allergies to any of the Minoxidil and Latanoprost drugs, having a history of heart disease and taking blood pressure medications, other types of alopecia such as alopecia areata, any systemic skin disease
Intervention groups
In this study, patients in one group consumed 1.5 cc of minoxidil solution, each solution equivalent to 20 drops twice a day, and in the other group, consumed a combination of latanoprost 0.005% and minoxidil 5% in the same way for 6 months.
Main outcome variables
Hair density; Severity of hair loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211228053553N1
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Amirhossein Bagherkamareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2613 8376
Email address
abagherkamareh@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-30, 1400/10/09
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of 5% Minoxidil solution alone with 5% Minoxidil solution and 0.005% Latanoprost in men with androgenetic alopecia
Public title
Evaluation of the effect of Latanaprost in the treatment of androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of the patient and his family to participate in the study
Confirmation of androgenetic alopecia by two experienced dermatologists based on Hamilton diagnostic criteria
Age 18 to 45 years
2 to 5 hair loss severity according to Hamilton criteria
The duration of hair loss is less than 10 years
Exclusion criteria:
History or observation of allergies to any of the drugs Minoxidil and Latanoprost, history of heart disease and use of antihypertensive drugs Receiving systemic treatment for androgenic alopecia during the 6 months before the study of other types of alopecia such as alopecia areata, telogen effluvium, anagen effluvium scarring alopecia, any systemic skin disease
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
50 eligible patients were selected and after studying the informed consent form; in a simple and individual random method with the help of random allocation software, each patient was assigned a number and divided into two groups by random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The two solutions of minoxidil and the combined solution of latanoprost and minoxidil are already prepared by the pharmacist in the same volume and with the same color and shape, and are marked with codes A and B and will be given to the patients. Therefore, the patient and the researcher will not have any information about the two prescription 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
Azadi Square, Hezar Jerib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.MUI.MED.REC.1399.1078
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
Severity of hair loss
Timepoint
Before and after the intervention
Method of measurement
By a skilled physician based on Hamilton-Norwood for male pattern hair loss
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the first intervention group consume 1.5 cc of minoxidil solution, each solution equivalent to 20 drops twice a day for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in the second intervention group consume a combination of latanoprost 0.005% and minoxidil 5% for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Nazila poostiyan
Street address
Soffe Boulevard, Isfahan
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
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
Shaghayegh Hagh Jooi Javanmard
Street address
Isfahan, Hezar Jerib St., School of Medicine, Vice Chancellor for Research
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
Nazila poostiyan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Hezar Jerib St., Al-Zahra Hospital, Dermatology Department
City
Isfahan
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
Hezar Jerib St., Al-Zahra Hospital, Dermatology Department
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
N.poostiyan@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amirhossein Bagherkamareh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bahonar street, Omodvar Ave
City
Tehran
Province
Tehran
Postal code
81977765511
Phone
+98 21 2613 8376
Email
abagherkamareh@ymail.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