Assessment of the effects of combination of topical minoxidil, biotin in comparison with topical minoxidil on mild to moderate androgenetic alopecia patients referring to dermatological clinics of Alzahra hospital
Find a topical drug for androgenetic alopecia that is more effective than the approved minoxidil drug.
Design
Clinical trial, with parallel groups, triple blind, randomized, sample size of 40 people, randomization with online randomization
Settings and conduct
This study is a triple blind randomized clinical trial performed at Al-Zahra Hospital in Isfahan. In this study, patients whose diagnosis has been clinically proven and who meet the inclusion criteria are reviewed and randomly divided into two groups. Before starting the treatment, the patients fill in the form related to the patient information and a standard photo is taken in each patient and the number of patients' hair in a specific area of the scalp is counted by a hair polarizer.
Participants/Inclusion and exclusion criteria
Patients who wish to participate in the study. Patients with androgenetic alopecia. Patients who have not been treated with finasteride or other anti-androgen therapy for the past 6 months.
Intervention groups
In the intervention group, the combination of minoxidil and biotin is used topically and in the control group, minoxidil alone is used.
Main outcome variables
Number of hairs; standard photographic score; hair regrowth score from patients' point of view; duration of disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200811048371N1
Registration date:2020-11-17, 1399/08/27
Registration timing:retrospective
Last update:2020-11-17, 1399/08/27
Update count:0
Registration date
2020-11-17, 1399/08/27
Registrant information
Name
Fatemeh Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 4542
Email address
f_mokhtari2004@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-15, 1399/04/25
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effects of combination of topical minoxidil, biotin in comparison with topical minoxidil on mild to moderate androgenetic alopecia patients referring to dermatological clinics of Alzahra hospital
Public title
Assessment of the effects of combination of topical minoxidil, biotin in comparison with topical minoxidil on mild to moderate androgenetic alopecia patients referring to dermatological clinics of Alzahra hospita
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with androgenetic alopecia
Patients who have not been treated with finasteride or other anti-androgen therapy for the past 6 months
Exclusion criteria:
Patients with other types of alopecia (such as alopecia areata, telogen effluvium, anagen effluvium, and scarring alopecia)
Receiving systemic treatment for androgenetic alopecia during the last 6 months
History of allergy to minoxidil, biotin
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in whom the inclusion criteria apply are unlikely and easy to enter the study and the treatment is assigned to the two groups randomly with the help of online randomization. The first group of patients treated with topical minoxidil alone and the other group of patients receiving a combination of minoxidil and biotin.
How to blind: Drugs in the same boxes with the same volume are given to a nurse outside the group and are coded in A and B, and the patient and the evaluating physician are unaware of the type of codes.
The data is analyzed in the form of coding, so the analyst is unaware of their allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The medicines are given to an out-of-group nurse in the same boxes with the same volume and are coded in A and B forms, and the patient and the evaluating physician are unaware of the type of codes.
The data is analyzed in the form of coding, so the analyst is unaware of their allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Science
Street address
Isfahan Universiy of Medical sciences, Hezarjarib Blvd.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-07-30, 1399/05/09
Ethics committee reference number
IR.MUI.MED.REC.1399.353
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Standard photographic score (reported by physician)
Timepoint
The effect of these two classes of drugs is measured at the end of week 24
Method of measurement
Physician evaluation of hair regrowth at the end of week 24: In this method, a physician who is blind to the study by comparing pre- and post-treatment photographs (taken by Standardized global photography in 4 views) according to a 7- point scale gives points (14). Given that all patients are examined by a physician, the probability of error in subjective assessment is low.Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = +1Moderately increased = +2Greatly increased = +3
2
Description
Hair regrowth score from patients' point of view
Timepoint
The effect of these two classes of drugs is measured at the end of week 24
Method of measurement
Evaluate the patient for hair regrowth at the end of week 24: In this method, the patient scores according to a 7-point scale: Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = + 1Moderately increased = + 2Greatly increased = +3
3
Description
number of hair
Timepoint
The effect of these two classes of drugs is measured at the end of week 24
Method of measurement
Hair count at the end of week 24 and comparison with the number of hairs at the beginning of the study: The results will be obtained through the hair polarizer (KC Technology).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The combination of minoxidil and biotin in a cc twice a day, due to the fact that minoxidil is dissolved in an alcoholic solvent and biotin in an aqueous solvent, to make a solvent system of 60% alcohol, 10% propylene glycol, 1% lactic acid and approximately 30% water is used. Minoxidil 5% at a rate of 1 ml and biotin at 5 mg / dl at a rate of 2 ml.
Category
Treatment - Drugs
2
Description
Control group: Using topical minoxidil as one cc twice a day, 60% alcohol, 10% propylene glycol, 1% lactic acid and approximately 30% water are used to make the solvent system.Minoxidil 5% is used in the amount of 1 ml.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan Alzahra Hospital
Full name of responsible person
Fatemeh Mokhtari
Street address
Alzahra Hospital, Sofeh Blvd., Isfahan
City
esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3629 4542
Email
f_mokhtari2004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghju Javanmard
Street address
Isfahan University of Medical Sciences, Hezarjarib Blvd
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Isfahan Uiversity of Medical Sciences, Hezarjarib Blvd., Isfahan
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3629 4542
Email
f_mokhtari2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Isfahan Uiversity of Medical Sciences, Hezarjarib Blvd., Isfahan
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3629 4542
Email
f_mokhtari2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Isfahan University of Medical Sciences, Hezarjarib Blvd., Isfahan
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3629 4542
Fax
Email
f_mokhtari2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available