Randomized Clinical Trial Comparing 5% Topical Minoxidil and 5% Topical Minoxidil plus Topical Betamethasone for the Treatment of Androgenetic Alopecia in Iranian Men
The purpose of this study is to compare the effect of topical minoxidil plus betamethasone versus topical minoxidil in patients with androgenetic alopecia. sixty subjects with androgenetic alopecia will be enrolled in the study and randomized to two equal groups. At the first visit a biopsy specimen and photograph will be taken from the scalp. the treatment will be initiated. every 4 weeks for 6 months they will be visited and photograph will be taken for comparison. subjects with the ages more than 25 and less than 40 will be enrolled in the study. Patients using drugs such as non-steroidal anti-inflammatory drugs; antiseptics and anti-fungal and anti-hypertensive will be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031727095N1
Registration date:2016-05-24, 1395/03/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-24, 1395/03/04
Registrant information
Name
Arash Bagheri Hamidi
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 88267994
Email address
arash.bagherihamidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences and Health Services
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Clinical Trial Comparing 5% Topical Minoxidil and 5% Topical Minoxidil plus Topical Betamethasone for the Treatment of Androgenetic Alopecia in Iranian Men
Public title
The effect of topical minoxidil plus betamethasone on androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Androgenetic alopecia; Age 25 and more; Age less than 40
Exclusion criteria: using of corticosteroids; NSAIDs; Cytotoxic agents; topical antiseptics and anti fungals; vasodilators; antibiotics; anti hypertensive medications; diuretics; spirnolactone; cimetidine; cyclosporin; finasteride; ketoconazole
Age
From 25 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences and Health Services
Street address
Velenjak St., Chamran Highway
City
Tehran
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.SBMU.SRC.REC.1394.11
Health conditions studied
1
Description of health condition studied
Androgenetic Alopecia
ICD-10 code
L64
ICD-10 code description
male-pattern baldness
Primary outcomes
1
Description
hair growing
Timepoint
2 months
Method of measurement
Trichoscopy
Secondary outcomes
empty
Intervention groups
1
Description
In the first visit we will take a biopsy specimen from scalp for routine histopathological studies. A 2*2 centimeters area of scalp will be photographed by a trichoscope for the purpose of counting. This group will receive topical 5% minoxidil plus betamethasone (0.1%) (45 milliliters) plus 70-degree alcohol up to 100 milliliters. The subjects will be visited every 4 weeks for 6 months. At each visit, their hairs will be photographed for the purposes of counting and comparing with previous photographs. After six month of initiating treatment subjects will be asked to discontinue therapy for 3 months and pattern and rate of hair loss will be analyzed.
Category
Treatment - Drugs
2
Description
In the first visit we will take a biopsy specimen from scalp for routine histopathological studies. A 2*2 centimeters area of scalp will be photographed by a trichoscope for the purpose of counting. This group will receive topical 5% minoxidil. The subjects will be visited every 4 weeks for 6 months. At each visit, their hairs will be photographed for the purposes of counting and comparing with previous photographs. After six month of initiating treatment subjects will be asked to discontinue therapy for 3 months and pattern and rate of hair loss will be analyzed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Dr Mehdi Gheysari
Street address
Qazvin St., South Kargar Ave.
City
Tehran
2
Recruitment center
Name of recruitment center
Shohadaye Tajrish Educational Hospital
Full name of responsible person
Dr Mehdi Gheysari
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr Mehdi Gheysari
Street address
Velenjak Street, Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr Mehdi Gheysari
Position
Assistant professor/Dermatology specialist
Other areas of specialty/work
Street address
Qazvin St, South Kargar Ave, Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
+98 21 5541 7547
Email
arash.bagheri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr Mehdi Gheysari
Position
Dermatology specialist
Other areas of specialty/work
Street address
Qazvin St., South kargar Ave., Loghman Hakim hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
arash.bagherihamidi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr Mehdi Gheysari
Position
Dermatology Specialist/assistant proffesor
Other areas of specialty/work
Street address
Makhsoos St, South Karegar Ave, Loghman Hakim hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
+98 21 5541 7547
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)