Comparing the efficacy of combination erbium, topical minoxidil and oral finasteride treatment with topical minoxidil and oral finasteride in patients with moderate to severe male androgenetic alopecia
The effect of erbium laser in the treatment of androgenetic alopecia
Design
Clinical trial with control group, parallel, quasi-randomized groups on 30 patients and for randomization couple and single days of referral is used.
Settings and conduct
The study is carried out on patients with moderate to severe androgenetic alopecia referred to medical centers of Isfahan University of Medical Sciences .After examination, history and satisfaction of patients who meet the inclusion criteria will be randomly assigned to two groups.The control group receives 5% topical minoxidil solution twice a day and oral finasteride 1 mg daily and the intervention group receives 6 sessions of erbium laser at two-week intervals and after 12 weeks, patients will be compared and evaluated by standard photography and trichogram at the beginning and end of treatment.
Participants/Inclusion and exclusion criteria
Patients with moderate to severe androgenic alopecia who do not have serious systemic diseases, psoriasis and lichen planus, as well as no history of hair transplantation and photosensitivity.
Intervention groups
The control group receives topical minoxidil and oral finasteride and in the intervention group, in addition to the two mentioned cases, erbium laser is also performed.
Main outcome variables
Hair thickness, number of hair, change of photographic score, patient satisfaction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210404050847N1
Registration date:2021-04-16, 1400/01/27
Registration timing:prospective
Last update:2021-04-16, 1400/01/27
Update count:1
Registration date
2021-04-16, 1400/01/27
Registrant information
Name
Zahra Zavareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3670 2116
Email address
z.zavare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of combination erbium, topical minoxidil and oral finasteride treatment with topical minoxidil and oral finasteride in patients with moderate to severe male androgenetic alopecia
Public title
Effect of Erbium Laser on Androgenetic Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with androgenetic alopecia in moderate to severe stages
Age over 20 years
Exclusion criteria:
Patients with other types of alopecia
Patients with psoriasis or lichen planus
Any serious systemic disease
Patients who are photosensitive
Patients who have performed hair transplants in the past.
Age
From 20 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Referring in couple date ,placed in intervention group and referring in single date, placed in control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Hezarjarib St., Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-20, 1399/12/30
Ethics committee reference number
IR.MUI.MED.REC.1399.1191
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Increase hair density and thickness.
Timepoint
At the beginning of the study and then 12 weeks later, which is the end of the study.
At the beginning of the study and then 12 weeks later, which is the end of the study.
Method of measurement
A 7-point questionnaire was allocated for patient satisfaction;also, a 7-point questionnaire developed by a physician based on a comparison of standard photographic scores and trichogram comparisons (checking the thickness and number of hairs).
Intervention groups
1
Description
Intervention group: Intervention group: receiving topical minoxidil 5% twice daily and oral finasteride one mg tablet daily and also performing erbium laser in 6 sessions with two-week intervals for 12 weeks
Category
Treatment - Other
2
Description
Control group: receiving topical minoxidil 5% twice daily and oral finasteride one mg tablet daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Zahra Zavareh
Street address
Soffe Blvd
City
Esfahan
Province
Isfehan
Postal code
8169663363
Phone
+98 31 3620 2020
Email
z.zavare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjoo javanmard
Street address
No.4 building.,Isfahan University of Medical Sciences.,Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Zahra Zavareh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 21, 9th Alley, South Farabi St., Sheikh Koleini Blvd.
City
Esfahan
Province
Isfehan
Postal code
8169663363
Phone
+98 31 3670 2116
Email
z.zavare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Zavareh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 21, 9th Alley, South Farabi St., Sheikh Koleini Blvd.
City
Esfahan
Province
Isfehan
Postal code
8169663363
Phone
+98 31 3670 2116
Email
z.zavare@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Zavareh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 21, 9th Alley, South Farabi St., Sheikh Koleini Blvd.
City
Esfahan
Province
Isfehan
Postal code
8169663363
Phone
+98 31 3670 2116
Email
z.zavare@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
No information
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