Comparing the efficacy of combination erbium laser and topical minoxidil treatment with topical minoxidil alone in patients with moderate to severe male androgenetic alopecia
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Protocol summary
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.
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 the intervention group, in addition to the mentioned treatment, 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.
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, in addition to the mentioned treatment, 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.
مطالعه روی بیماران مبتلا به آلوپسی آندروژنتیک متوسط تا شدید مراجعه کننده به مراکز درمانی دانشگاه علوم پزشکی اصفهان انجام میشود.پس از معاینه،اخذ شرح حال و رضایت بیمارانی که معیارهای ورود به مطالع را دارند به صورت تصادفی در دو گروه قرار می گیرند.گروه کنترل روزانه دو نوبت محلول ماینوکسیدیل موضعی 5درصد دو بار در روز و فیناستراید خوراکی یک میلی گرم دریافت می کنند و گروه مداخله علاوه بر درمان های ذکر شده 6 جلسه لیزر اربیوم با فواصل دو هفته ای دریافت می کنند و بعد از 12 هفته بیماران به وسیله فوتوگرافی استاندارد و تریکوگرام که در شروع و پایان درمان انجام شده مقایسه و ارزیابی می شوند.
مطالعه روی بیماران مبتلا به آلوپسی آندروژنتیک متوسط تا شدید مراجعه کننده به مراکز درمانی دانشگاه علوم پزشکی اصفهان انجام میشود.پس از معاینه،اخذ شرح حال و رضایت بیمارانی که معیارهای ورود به مطالع را دارند به صورت تصادفی در دو گروه قرار می گیرند.گروه کنترل روزانه دو نوبت محلول ماینوکسیدیل موضعی 5درصد دریافت می کنند و گروه مداخله علاوه بر درمان ذکر شده 6 جلسه لیزر اربیوم با فواصل دو هفته ای دریافت می کنند و بعد از 12 هفته بیماران به وسیله فوتوگرافی استاندارد و تریکوگرام که در شروع و پایان درمان انجام شده مقایسه و ارزیابی می شوند.
مطالعه روی بیماران مبتلا به آلوپسی آندروژنتیک متوسط تا شدید مراجعه کننده به مراکز درمانی دانشگاه علوم پزشکی اصفهان انجام میشود.پس از معاینه،اخذ شرح حال و رضایت بیمارانی که معیارهای ورود به مطالع را دارند به صورت تصادفی در دو گروه قرار می گیرند.گروه کنترل روزانه دو نوبت محلول ماینوکسیدیل موضعی 5درصد دو بار در روز و فیناستراید خوراکی یک میلی گرم دریافت می کنند و گروه مداخله علاوه بر درمان های ذکر شده 6 جلسه لیزر اربیوم با فواصل دو هفته ای دریافت می کنند و بعد از 12 هفته بیماران به وسیله فوتوگرافی استاندارد و تریکوگرام که در شروع و پایان درمان انجام شده مقایسه و ارزیابی می شوند.
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.
The control group receives topical minoxidil and in the intervention group, in addition to the mentioned treatment, erbium laser is also performed.
The control group receives topical minoxidil and oral finasteride and in the intervention group, in addition to the two mentioned casestreatment, erbium laser is also performed.
گروه کنترل ماینوکسیدیل موضعی و فیناستراید خوراکی دریافت می کنند و در گروه مداخله علاوه بر دو مورد ذکر شده لیزر اربیوم نیز انجام میگیرد.
گروه کنترل ماینوکسیدیل موضعی دریافت می کنند و در گروه مداخله علاوه بر مورد ذکر شده لیزر اربیوم نیز انجام میگیرد.
گروه کنترل ماینوکسیدیل موضعی و فیناستراید خوراکی دریافت می کنند و در گروه مداخله علاوه بر دو مورد ذکر شده لیزر اربیوم نیز انجام میگیرد.
General information
empty
Due to the reluctance of most patients to use finasteride and considering that minoxidil alone is also a standard and approved treatment, finasteride was excluded from the study.
Due to the reluctance of most patients to use finasteride and considering that minoxidil alone is also a standard and approved treatment, finasteride was excluded from the study.
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به علت عدم تمایل اکثر بیماران به استفاده از فیناستراید و با توجه به اینکه ماینوکسیدیل به تنهایی نیز درمان استاندارد و مورد تایید است،فیناستراید از مطالعه حذف گردید.
به علت عدم تمایل اکثر بیماران به استفاده از فیناستراید و با توجه به اینکه ماینوکسیدیل به تنهایی نیز درمان استاندارد و مورد تایید است،فیناستراید از مطالعه حذف گردید.
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
Comparing the efficacy of combination erbium laser and topical minoxidil treatment with topical minoxidil alone in patients with moderate to severe male androgenetic alopecia
Comparing the efficacy of combination erbium, laser and topical minoxidil and oral finasteride treatment with topical minoxidil and oral finasteridealone in patients with moderate to severe male androgenetic alopecia
مقایسه اثربخشی درمان ترکیبی لیزر اربیوم، ماینوکسیدیل موضعی و فیناستراید خوراکی با ماینوکسیدیل موضعی و فیناستراید خوراکی در بیماران مبتلا به آلوپسی آندروژنتیک مردانه متوسط تا شدید
مقایسه اثربخشی درمان ترکیبی لیزر اربیوم و ماینوکسیدیل موضعی با ماینوکسیدیل موضعی به تنهایی در بیماران مبتلا به آلوپسی آندروژنتیک مردانه متوسط تا شدید
مقایسه اثربخشی درمان ترکیبی لیزر اربیوم، و ماینوکسیدیل موضعی و فیناستراید خوراکی با ماینوکسیدیل موضعی و فیناستراید خوراکیبه تنهایی در بیماران مبتلا به آلوپسی آندروژنتیک مردانه متوسط تا شدید
Intervention groups
#1
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
Intervention group: receiving topical minoxidil 5% twice daily and performing erbium laser in 6 sessions with two-week intervals for 12 weeks
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
گروه مداخله: دریافت ماینوکسیدیل موضعی 5 درصد روزانه دو بار و فیناستراید خوراکی روزانه یک قرص یک میلی گرمی و هچنین انجام لیزر اربیوم به تعداد 6 جلسه با فواصل دو هفته ای به مدت 12 هفته
گروه مداخله: دریافت ماینوکسیدیل موضعی 5 درصد روزانه دو بار و انجام لیزر اربیوم به تعداد 6 جلسه با فواصل دو هفته ای به مدت 12 هفته
گروه مداخله: دریافت ماینوکسیدیل موضعی 5 درصد روزانه دو بار و فیناستراید خوراکی روزانه یک قرص یک میلی گرمی و هچنین انجام لیزر اربیوم به تعداد 6 جلسه با فواصل دو هفته ای به مدت 12 هفته
#2
Control group: receiving topical minoxidil 5% twice daily and oral finasteride one mg tablet daily.
Control group: receiving topical minoxidil 5% twice daily.
Control group: receiving topical minoxidil 5% twice daily and oral finasteride one mg tablet daily.
گروه کنترل: دریافت ماینوکسیدیل موضعی 5 درصد روزانه دو بار و فیناستراید خوراکی روزانه یک قرص یک میلی گرمی.
گروه کنترل: دریافت ماینوکسیدیل موضعی 5 درصد روزانه دو بار .
گروه کنترل: دریافت ماینوکسیدیل موضعی 5 درصد روزانه دو بار و فیناستراید خوراکی روزانه یک قرص یک میلی گرمی.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: shaghayegh haghjoo javanmard
Full name of responsible person - Persian: شقایق حق جو جوانمرد
Street address - English: No.4 building.,Isfahan University of Medical Sciences.,Hezar Jerib St
Street address - Persian: خیابان هزارجریب،دانشگاه علوم پزشکی اصفهان،ساختمان شماره4 شماره
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 5149
Fax:
Email: research@mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shaghayegh Haghjoo javanmard
Full name of responsible person - Persian: شقایق حق جو جوانمرد
Street address - English: No.4 building.,Esfahan University of Medical Sciences.,Hezar Jerib St
Street address - Persian: خیابان هزارجریب،دانشگاه علوم پزشکی اصفهان،ساختمان شماره4 شماره
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 5149
Fax:
Email: research@mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: shaghayegh haghjooShaghayegh Haghjoo javanmard Full name of responsible person - Persian: شقایق حق جو جوانمرد Street address - English: No.4 building.,Isfahanbuilding.,Esfahan University of Medical Sciences.,Hezar Jerib St Street address - Persian: خیابان هزارجریب،دانشگاه علوم پزشکی اصفهان،ساختمان شماره4 شماره City - English: Esfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3668 5149 Fax: Email: research@mui.ac.ir Web page address:
Protocol summary
Study aim
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 the intervention group, in addition to the mentioned treatment, 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 in the intervention group, in addition to the mentioned treatment, erbium laser is also performed.
Main outcome variables
Hair thickness, number of hair, change of photographic score, patient satisfaction.
General information
Reason for update
Due to the reluctance of most patients to use finasteride and considering that minoxidil alone is also a standard and approved treatment, finasteride was excluded from the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20210404050847N1
Registration date:2021-04-16, 1400/01/27
Registration timing:prospective
Last update:2022-11-23, 1401/09/02
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 laser and topical minoxidil treatment with topical minoxidil alone 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: receiving topical minoxidil 5% twice daily and 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.
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.,Esfahan 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