Determination of the effectiveness of 0.5, 2.5 and 5 mg doses of oral minoxidil in the treatment of female pattern androgenic alopecia
Design
Clinical trial with parallel groups, double-blind, randomized with sealed envelopes, phase 2 on 60 patients
Settings and conduct
This study is interventional in which 60 patients with female pattern hair loss referred to the dermatology clinic of Rasoul Akram Hospital are randomly divided into 3 groups A, B and C. For each patient, a questionnaire including demographic and clinical information with sinclair scale will be performed at the beginning of the visit by a dermatologist. Also, in each session, clinical imaging will be performed with the iPhone device as well as dermatoscopy in the frontal and vertex areas. The patient does not know in which treatment group he is. Also, the results are evaluated by a blinded dermatologist and statistical specialist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with clinical diagnosis of female pattern hair loss and Sinclair scale one to four.
Exclusion criteria: patients receiving medication other than vitamins or minerals for alopecia; pregnancy; lactation; abnormal tests.
Intervention groups
Group A patients are given half a milligram daily; group B patients are given two and a half milligrams daily and group C patients are given five milligrams of oral minoxidil daily.
Main outcome variables
Improvement rate with sinclair scale, clinical and dermatoscopic images
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220322054341N1
Registration date:2022-04-14, 1401/01/25
Registration timing:prospective
Last update:2022-04-14, 1401/01/25
Update count:0
Registration date
2022-04-14, 1401/01/25
Registrant information
Name
masoumeh roohaninasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
rohaninasab.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of 0.5, 2.5 and 5 mg oral minoxidil doses in the treatment of female pattern hair loss
Public title
Comparison of the effect of 0.5, 2.5 and 5 mg doses of oral minoxidil in the treatment of female pattern of hereditary hormonal hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with clinical diagnosis of female pattern hair loss
Sinclair scale one to four
Age range 18 to 50 years old
Conscious consent to enter the study and the possibility of attending visits and follow-up sessions
Exclusion criteria:
Patients taking medication other than vitamins or minerals for alopecia
Pregnancy or breastfeeding
Patients with serious internal disease, especially heart disease or comorbidities at the treatment site
Psychiatric patients
Abnormal tests at baseline
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method, patients who refer to the dermatology clinic of Rasoul Akram Hospital are divided into three groups, so that out of 60 sealed bags, one bag is randomly selected for each patient. Each letter contains A, B, or C. Group A patients are given half a milligram daily, group B patients are given two and a half milligrams daily, and group C patients are given five milligrams of oral minoxidil daily.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know in which treatment group he is. Also, the results are evaluated by a blinded dermatologist and the data is analyzed by a blinded statistical specialist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine, Iran University of medical sciences
Street address
School of medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.IUMS.FMD.REC.1400.520
Health conditions studied
1
Description of health condition studied
Female pattern androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Improvement rate
Timepoint
3 and 6 months after starting treatment
Method of measurement
By sinclair scale, clinical and dermatoscopic images (Determine the number and thickness of hair shafts per square centimeter)
Secondary outcomes
1
Description
Safety
Timepoint
3 and 6 months after starting treatment
Method of measurement
Asking the patient about the side effects of treatment
2
Description
Tolerability
Timepoint
3 and 6 months after starting treatment
Method of measurement
With Investigator Assessment of Tolerability scale (zero, low, medium and high or sufficient)
3
Description
Patient satisfaction
Timepoint
3 and 6 months after starting treatment
Method of measurement
With Caregiver treatment satisfaction (CTS) questionnaire (completely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and completely dissatisfied)
Intervention groups
1
Description
Intervention group A: half a milligram of oral minoxidil daily for 6 months
Category
Treatment - Drugs
2
Description
Intervention group B: two and a half milligrams of oral minoxidil daily for 6 months
Category
Treatment - Drugs
3
Description
Intervention group C: five milligrams of oral minoxidil daily for 6 months