Protocol summary
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Study aim
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The effect of erbium laser in the treatment of androgenetic alopecia
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Design
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Clinical trial with control group, parallel, quasi-randomized groups on 30 patients and for randomization couple and single days of referral is used.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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The control group receives topical minoxidil and in the intervention group, in addition to the mentioned treatment, erbium laser is also performed.
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Main outcome variables
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Hair thickness, number of hair, change of photographic score, patient satisfaction.
General information
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2021-04-16, 1400/01/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-22, 1400/03/01
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Expected recruitment end date
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2022-05-22, 1401/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of Erbium Laser on Androgenetic Alopecia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 20 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Referring in couple date ,placed in intervention group and referring in single date, placed in control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-20, 1399/12/30
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Ethics committee reference number
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IR.MUI.MED.REC.1399.1191
Health conditions studied
1
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Description of health condition studied
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Androgenetic alopecia
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ICD-10 code
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L64
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ICD-10 code description
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Androgenic alopecia
Primary outcomes
1
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Description
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Increase hair density and thickness.
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Timepoint
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At the beginning of the study and then 12 weeks later, which is the end of the study.
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Method of measurement
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Trichogram and standard photography
Secondary outcomes
1
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Description
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Patient satisfaction score, physician satisfaction score.
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Timepoint
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At the beginning of the study and then 12 weeks later, which is the end of the study.
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Method of measurement
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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
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Description
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Intervention group: receiving topical minoxidil 5% twice daily and performing erbium laser in 6 sessions with two-week intervals for 12 weeks
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Category
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Treatment - Other
2
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Description
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Control group: receiving topical minoxidil 5% twice daily.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available