Comparative efficacy of topical finasteride and topical minoxidil versus topical minoxidil alone in androgenic alopecia in men referring to educational center of Isfahan University of medical sciences
Design
Clinical trial with control group, with a parallel group, double blind, randomized, phase 3 on 40 patients. Random number table was used for randomization.
Settings and conduct
Determining the severity of hair loss by an independent and skilled physician based on the Hamilton and Norwood scale. Counting patients' non-volus hair at the level of 1 cm2 in a specific area of the scalp (Hair polarizer)(KC Technology). Standardized global photography. Counting the hairs at the end of week 12 and comparing with the number of hairs at the beginning of the study. Evaluation of the patient for hair regrowth at the end of week 12 according to a 7-point scale. Physician evaluation of hair regrowth at the end of week 12 by comparing pre- and post-treatment photographs according to a 7-point scale. The evaluating physician is not aware of the type of treatment performed.
Participants/Inclusion and exclusion criteria
Men with moderate to severe androgenic alopecia
Intervention groups
The control group received 5% topical minoxidil alone. The experimental group received a topical combination of finasteride 1% and minoxidil 5%.
Main outcome variables
Hair count and hair thickness.
Standard photographic score reported by the physician.
Patient satisfaction score
General information
Reason for update
Acronym
AGA
IRCT registration information
IRCT registration number:IRCT20191203045592N2
Registration date:2021-02-10, 1399/11/22
Registration timing:prospective
Last update:2021-02-10, 1399/11/22
Update count:0
Registration date
2021-02-10, 1399/11/22
Registrant information
Name
Samin Nabavinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3131 7715
Email address
saminstrs@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy study of topical finasteride and topical minoxidil versus topical minoxidil alone in male patients with androgenic alopecia.
Public title
Comparative efficacy study of topical finasteride in androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men 18-40 years old with moderate to severe androgenic alopecia.
Patients should not be treated with oral finasteride or other anti-androgen therapy for the past 6 months.
Willingness to participate in the study and fill out the informed consent form.
Their diagnosis has been clinically proven and other causes of hair loss have been ruled out.
Exclusion criteria:
Patients with other types of alopecia such as alopecia areata or telogen effluvium.
Any serious systemic disease
Receiving systemic treatment for androgenic alopecia during the last 6 months.
Age
From 18 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluating physician and patient are not informed about the type of treatment performed on the patient.
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
Medical school, Isfahan University of Medical sciences, Hezar Jerib St. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.MUI.MED.REC.1399.909
Health conditions studied
1
Description of health condition studied
androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair count
Timepoint
At the start of study and 12 weeks later
Method of measurement
Scalp & Hair Polarizing HMS System (KC Technology Company; Korea)
2
Description
Hair thickness
Timepoint
At the start of study and 12 weeks later
Method of measurement
Scalp & Hair Polarizing HMS System (KC Technology Company; Korea)