To compare efficacy of low dose oral minoxidil Versus topical minoxidil solution for the treatment of androgenetic alopecia.
Design
Community based, parallel group, double blind, randomized controlled trial.
Settings and conduct
In this study 80 patients with moderate to severe androgenetic alopecia are enrolled after explaining thoroughly the course and purpose of the study. Patients are randomly assigned to two groups one receiving oral minoxidil tablet and the other receiving 5% topical minoxidil solution.
After 6 months of treatment patients are compared and evaluated by standard photography and patient's satisfaction score obtained at the beginning and end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: clinical diagnosis of AGA; age range between 18-55; patients who haven't received topical or systemic treatment for AGA within 3 months prior to the study.
Exclusion criteria: those with other causes of hair loss such as inflammatory or scarring alopecia; any other types of alopecia.
Intervention groups
Intervention group: on oral minoxidil tablet initial starting dose of 2.5 mg per day then gradually increasing the dose to maximum 5 mg per day for 6 months
Control group on topical minoxidil solution 5% once daily for six months.
Main outcome variables
Hair thickness; number of hairs; change in photographic pictures and patient's satisfaction score.
General information
Reason for update
Acronym
AGA Androgenetic alopecia
IRCT registration information
IRCT registration number:IRCT20210823052264N7
Registration date:2024-08-16, 1403/05/26
Registration timing:registered_while_recruiting
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-01, 1403/03/12
Expected recruitment end date
2024-11-01, 1403/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of low dose oral minoxidil Versus topical minoxidil solution for the treatment of androgenetic alopecia.
Public title
Efficacy of low dose oral minoxidil Versus topical minoxidil solution for the treatment of androgenetic alopecia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of AGA score 2-5 on Norwood-Hamilton classification.
Age between 18-55 years.
Patients who haven't received topical or systemic treatment for AGA within 3 months prior to the study.
Exclusion criteria:
Those with other causes of hair loss Such as inflammatory or scarring alopecia.any other types of alopecia
History of severe systemic diseases ( renal, cardiovascular and hepatic)
History of some hormonal disorders.
History of hypertension,hypotension or on any antihypertensive therapy
Hypersensitivity to minoxidil.
Age
From 18 years old to 55 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by lottery method (using sealed envelops)
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded study (participant and data analyser are blinded)
Total hair density,hair thickness and total number of vellus and terminal hairs.
Timepoint
Before start of study and after 1,2,3,6 Months after start of study
Method of measurement
Photographic pictures
2
Description
Patient's satisfaction score
Timepoint
Before study and after 6 months
Method of measurement
Interviewing with the patients
Secondary outcomes
1
Description
Any side effects after taking minoxidil orally or topically
Timepoint
3 monthly
Method of measurement
Interviewing with the patients and clinical examination
Intervention groups
1
Description
Intervention group: on oral minoxidil tablet initial starting dose of 2.5 mg per day then gradually increasing the dose to maximum 5 mg per day for 6 months
Category
Treatment - Drugs
2
Description
Control group: on topical minoxidil solution 5% once daily for six months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Quetta
Full name of responsible person
Moniba saeed sheikh
Street address
CMH Quetta
City
Quetta
Postal code
08762
Phone
+92 81 9202970
Email
saeedmoniba@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Quetta
Full name of responsible person
Moniba Saeed Sheikh
Street address
CMH Quetta
City
Quetta
Postal code
08762
Phone
+92 81 9202970
Fax
Email
saeedmoniba@gmail.com
Web page address
Grant name
CMH Quetta
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Quetta
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
Combined Military Hospital
Full name of responsible person
Moniba Saeed Sheikh
Position
Registrar
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
CMH Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 81 9202970
Email
saeedmoniba@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Quetta
Full name of responsible person
Moniba Saeed Sheikh
Position
Registrar
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
CMH Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 81 9202970
Email
saeedmoniba@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital
Full name of responsible person
Moniba Saeed Sheikh
Position
Registrar
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
CMH Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 81 9202970
Email
saeedmoniba@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