This double-blind controlled clinical trial will recruit 50 male and female patients (age: 17-45 years old) with androgenetic alopecia (AGA) who visit the dermatology clinics of Alzahra Hospital, Khorshid Hospital, and Sedighe Tahereh Research Center (Isfahan, Iran). Table of random numbers will be used for random allocation of the patients. Both groups will have to apply 20 drops of a minoxidil topical solution 5% on the affected areas twice daily. The intervention group will also receive low level light laser therapy (LLLT) using a laser comb two-three times a week for 24 weeks. Laser sessions will last for 20 minutes and will be held at Arman Laser Clinic. The patients will be included if the AGA diagnosis is confirmed by careful clinical examination, patient history, Ludwig and Hamilton’s criteria, and ruling other causes of hair loss out. A demographic questionnaire will be filled out at baseline. Two researchers unaware of grouping will perform phototrichogram tests at baseline and after three, six, nine, and 12 months. Changes in hair density and hair shaft diameter at the affected site, hair regrowth (based on the patient and researcher’s opinion), and patient satisfaction will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022726780N1
Registration date:2016-05-02, 1395/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-02, 1395/02/13
Registrant information
Name
Samane Mozafarpoor
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3628 9559
Email address
s_mozafarpoor@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-12-11, 1394/09/20
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of low-level light laser therapy plus minoxidil 5% and minoxidil 5% alone in the treatment of androgenetic alopecia
Public title
Comparing the efficacy of low-level light laser therapy plus minoxidil 5% and minoxidil 5% alone in the treatment of androgenetic alopecia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate; absence of other causes of hair loss; types 1-4 on Fitzpatrick scale; stages 3-6 on Norwood Hamilton Scale (for male patter baldness); stages 2-3 on the Ludwig Scale for hair loss in women; no history of finasteride, antiandrogens (e.g. cyproterone, spironolactone, ketoconazole, and flutamide), topical estrogen, progesterone, tamoxifen, anabolic steroids, drugs potentially associated with hypertrichosis (e.g. cyclosporine, diazoxide, phenytoin, oral glucocorticoids, lithium, and phenothiazine during the three-month period before the study.
Exclusion criteria: using the above-mentioned medicines during the study; lack of adherence to treatment protocol; hair transplant; any medical conditions leading to hair loss (e.g. HIV/AIDS, connective tissue disease, and inflammatory bowel disease); development of endocrinopathies such as PCO, ovarian and adrenal gland tumors, and hypothyroidism.
Age
From 17 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IRMUIREC13943912
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L-64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair density
Timepoint
Before the intervention, 3, 6, 9, and 12 months after the intervention
Method of measurement
Phototrichogram
2
Description
Hair shaft diameter
Timepoint
Before the intervention, 3, 6, 9, and 12 months after the intervention
Method of measurement
Phototrichogram
3
Description
Patient satisfaction
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Questionnaire
4
Description
Hair regrowth based on patient's opinion
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Visual analog scale
5
Description
Hair regrowth based on physician's opinion
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Digital image and observation
Secondary outcomes
1
Description
Headache
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Asking patients
2
Description
Erythema
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Asking patients
3
Description
Itching
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Asking patients
4
Description
Hypopigmentation
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Observation and asking patients
5
Description
Hyperpigmentation
Timepoint
3, 6, 9, and 12 months after the intervention
Method of measurement
Observation and asking patients
Intervention groups
1
Description
Intervention: 20 drops of a minoxidil topical solution 5% on the affected areas twice daily plus 20-minute sessions of low level light laser therapy (LLLT) using a laser comb (LDU 8024PN/8024BN, Germany)two-three times a week for 24 weeks.
Category
Treatment - Devices
2
Description
Control: 20 drops of a minoxidil topical solution 5% (Pak Darou, Iran) on the affected areas twice daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic, Alzagra Hospital
Full name of responsible person
Samane Mozafarpoor
Street address
Sofeh Blv.
City
Isfahan
2
Recruitment center
Name of recruitment center
Sedighe Tahereh Dermatology and Sexually Transmitted Diseases Research Center
Full name of responsible person
Samane Mozafarpoor
Street address
Khoram St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Bahram Nasr Esfahani
Street address
Hezar Jarib St.
City
Isfahan
Grant name
--
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Samane Mozafarpoor
Position
Resident
Other areas of specialty/work
Street address
Hejar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
s_mozafarpoor@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Diseases and Leishmaniasis Research Center
Full name of responsible person
Dr Gita Faghihi
Position
Professor
Other areas of specialty/work
Street address
Sofeh Blv.
City
Isfahan
Postal code
8187698191
Phone
+98 31 3663 3061
Fax
Email
g_faghihi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Samane Mozafarpoor
Position
Resident
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
8174675731
Phone
+98 31 3792 9001
Fax
+98 31 3668 8597
Email
s_mozafarpoor@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)