This study aimed to compare the effect of topical and oral minoxidil in the treatment of androgenic alopecia.
Design
A clinical trial with a control group, blinded outcome assessment, randomized, phase 3 on 60 patients. Random allocation software was used for randomization.
Settings and conduct
This study will be performed in Isfahan Al-Zahra Hospital and clinics affiliated with Isfahan University of Medical Sciences.
Images of the vortex at 12, 16, and 24 centimeters distances from Glabla are recorded in all patients with a standard global camera and dermoscopy with 20x magnification and polarized light at the beginning of the intervention and three months and six mon.
Patients' evaluation is based on images. two dermatologists will score the changes in hair density between images from zero to ten.
Participants/Inclusion and exclusion criteria
Inclusion criteria: androgenic alopecia patients who are in the clinical examination according to Hamilton and Norwood system in grade 2-4 with male pattern alopecia and Ludwig system in grade 1-2 with the female pattern.
Exclusion criteria: cardiovascular disease; hypotension; history of drug allergy; pregnancy; lactation.
Intervention groups
Intervention group: patients take one mg of minoxidil capsules daily for six months.
Control group: patients spray 8 puffs of 5% minoxidil solution on the scalp once a day.
Main outcome variables
Change in hair density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220117053743N1
Registration date:2022-03-11, 1400/12/20
Registration timing:prospective
Last update:2022-03-11, 1400/12/20
Update count:0
Registration date
2022-03-11, 1400/12/20
Registrant information
Name
Aida Farmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6408
Email address
aida.farmani.med@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of topical and oral Minoxidil in the treatment of androgenic alopecia
Public title
Effect of oral minoxidil in treatment of androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with male pattern alopecia according to Hamilton and Norwood system are in grade 2-4
Patients with Female pattern alopecia according to the Ludwig system are in grade 1-2
Exclusion criteria:
Cardiovascular disease and hypotension
Kidney Diseases
History of drug allergy
Pregnancy
Lactation
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two separate groups by random allocation software
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor and data analyst are unaware of the intervention
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
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.MUI.MED.REC.1400.712
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
Standardized global photography
Timepoint
Before the start of the study and 3, 6 months after the start of the intervention
Method of measurement
Based on scoring by two dermatologist
2
Description
Dermoscopy imaging
Timepoint
Before the start of the study and 3, 6 months after the start of the intervention
Method of measurement
Based on scoring by two dermatologist
Secondary outcomes
1
Description
Change in hair density
Timepoint
At the beginning of the study (before the intervention) and 3, 6 months after the intervention
Method of measurement
Scoring by two dermatologists
Intervention groups
1
Description
Intervention group: A group of 30 patients will be administered with minoxidil capsules at a dose of one milligram per day for six months
Category
Treatment - Drugs
2
Description
Control group: A group of 30 patients will be treated with 5% topical minoxidil eight puffs a day for six months.