Determining and comparing the effectiveness of topical Nano-minoxidil and minoxidil on treatment of patients with androgenetic alopecia aged between 18-50 years
Determining and comparing the effectiveness of topical Nano-minoxidil and minoxidil on treatment of patient with androgenetic alopecia
Design
Randomized clinical trial with control and parallel groups, double blind, performed on 84 patients. In this study, permutation block method was used to generate a sequence of random allocation of individuals to the study groups.
Settings and conduct
This study will be conducted on 84 patients with androgenetic alopecia referring to Imam Reza Hospital in Mashhad. After filling out the informed consent form, the patients will be divided into intervention and control groups using block randomization. Patients in the intervention group will be treated with Nano-minoxidil and patients in the control group with minoxidil on a daily basis for 6 months. In this double-blind study, both patients and outcome assessors will be unaware of how patients were assigned to control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients are between 18 and 50 with androgenetic alopecia (Sinclair stage 2-5); Exclusion criteria: hypertension, skin lesions such as psoriasis or blister on the scalp, severe Seborrhoeic dermatitis, history of allergic reaction to minoxidil
Intervention groups
Patients in the intervention group are treated with 1 cc of topical 0.5% Nano-minoxidil and patients in the control group with 1 cc of topical 5% minoxidil daily for 6 months.
Main outcome variables
Hair density and diameter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N62
Registration date:2023-06-13, 1402/03/23
Registration timing:prospective
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-15, 1402/03/25
Expected recruitment end date
2024-02-12, 1402/11/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and comparing the effectiveness of topical Nano-minoxidil and minoxidil on treatment of patients with androgenetic alopecia aged between 18-50 years
Public title
Effectiveness of topical Nano-minoxidil and minoxidil on treatment of patients with androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are between 18 and 50 years of age
Patients with androgenetic alopecia (Sinclair stage 2-5)
Exclusion criteria:
Hypertension
Skin lesions such as psoriasis or blister on the scalp
Severe Seborrhoeic dermatitis
History of allergic reaction to minoxidil
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation block method was used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequence was performed using random allocation software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessors are fully aware of the subject of the subject, purpose, and procedure of the study. However, in order to prevent prediction of results and introduction of error into the study, they are unaware of the type of grouping and how patients are assigned to control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.MUMS.IRH.REC.1401.022
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair density
Timepoint
Every 2 months for 6 months
Method of measurement
Trichoscopy
2
Description
Hair diameter
Timepoint
Every 2 months for 6 months
Method of measurement
Trichoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients are treated with 1 cc of 0.5% Nano-minoxidil (produced by Dr. Ali Moradi and Dr. Majid Daroudi in the nanobiotechnology department of the medical school of Mashhad university of Medical Sciences) locally on the scalp on a daily basis for 6 months.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients are treated with 1 cc of 5% minoxidil locally on the scalp on a daily basis for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Rozhan Farhadi
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 491 4794
Email
rozhanf45@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shatila Torabi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
TorabiSh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shatila Torabi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
TorabiSh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shatila Torabi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
TorabiSh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes.
From where data/document is obtainable
The data can be accessed through sending an email to Dr. Rozhan Farhadi via rozhanf45@gmail.com.
What processes are involved for a request to access data/document
After sending a request email to the researcher responsible for data collection, Dr. Rozhan Farhadi, at rozhanf45@gmail.com, the data will be provided within 1 month.