Comparison of the therapeutic effects of Oral Minoxidil Tablets in dose of 0.25 mg with topical Minoxidil Therapeutic Effects in woman Patients with Androgenic Alopecia
Design
Patients are subjected to weekly intervals up to one month, then monthly for up to three months, and then every three months for visits under necessary trials. At the end of one year, the therapeutic effects of the two groups based on the three criteria of Sinclair scale, shedding scale and Trichoscopy and the side effects of each drug will be assessed.
Settings and conduct
Patients referred to Dermatology Clinic of Imam Reza Hospital and Ghaem Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women aged 18 to 50 with androgenetic alopecia of female pattern (with Sinclair stage 2-5)
Non-compliance criteria:
• Other causes of hair loss, including inflammatory and cicatricial hair loss
• The presence of other symptoms of hyperandrogenism (in particular, malaise and hirsutism)
• Severe systemic disease (cardiovascular - renal - hepatic)
• History of pressure drop or baseline blood pressure less than 60/90 mmHg
• The patient's desire for pregnancy during one year of study
• Use of any effective medication on alopecia, including hormonal medications
Intervention groups
The selected patients were randomly divided into two groups and the first group (30 patients) daily received oral minoxidil (0.25 mg) and topical placebo (one cc twice daily) . The second one (30 patients) treated with topical minoxidil ( One cc of 2% solution twice a day) and oral placebo.
Main outcome variables
Hair loss condition based on Sinclair scale and shedding scale
Study of density and thickness of hair by trichoscopy
Measurement time: every 3 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181011041311N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Vahideh Sabeti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3849 4720
Email address
sabetiv@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A triple-blind randomized clinical trial on the effectiveness of oral minoxidil in the treatment of women with Androgenetic Alopecia
Public title
The effectiveness of oral minoxidil in women with scalp hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with female pattern hair loss androgenic alopcia ( with sinclair stgae between 2 and 5) based on clinical diagnosis and histopathology
Age: between 18 and 50
Exclusion criteria:
Other causes of hair loss, including inflammatory and cicatricial hair loss
The presence of other symptoms of hyperandrogenism (in particular, malaise and hirsutism), which is also evident in laboratory examination of hormonal disorders supported by polycystic ovaries, ovarian and adrenal tumors.
Severe systemic disease (cardiovascular - renal - hepatic)
A history of pressure drop or blood pressure less than 90/60 mmHg
The patient's desire for pregnancy during one year is under study
Taking any effective medication for alopecia, including hormonal medications
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: blocked
This method is used to prevent significant imbalances in the number of participants assigned to each group.
Allocation Concealment: Sealed envelopes
The method used to generate a random assignment sequence: A random number table using www.randomization.com
Blinding (investigator's opinion)
Triple blinded
Blinding description
Individuals under study, evaluators and analysts will be unaware of the intervention and control groups.
Placebo
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
Opposite to Daneshgah 18 St, Mashhad University of Medical Sciences, Deputy of Research and Technology of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
ir.mums.medical.rec.1397.536
Health conditions studied
1
Description of health condition studied
Female pattern hair loss (FPHL) androgenic alopcia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair loss condition
Timepoint
Every 3 months
Method of measurement
based on Sinclair scale and shedding scale
2
Description
evaluating the density and thickness of the hair
Timepoint
Every 3 months
Method of measurement
By trichoscopy
Secondary outcomes
1
Description
Blood pressure, weight
Timepoint
Weekly up to one month then monthly up to three months and then every three months
Method of measurement
Pressure gauge cuff, Weight gauge
2
Description
liver, renal and electrolyte tests
Timepoint
The third and 12th month after starting treatment
Method of measurement
Blood sampling
Intervention groups
1
Description
Intervention group: Daily treatment with Oral Minoxidil Tablets (0.25 mg) and topical Placebo (1 CC twice a day) for one year
Category
Treatment - Drugs
2
Description
Control group: Daily treatment with topical minoxidil (1 cc of 2% solution twice daily) and oral placebo for one year
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Reza Hospital Hospital in Mashhad
Full name of responsible person
Dr Sadegh Vahabi Amlashi
Street address
The beginning of Daneshgah St, Mashhad, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5726
Email
emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Dermatology Clinic of Ghaem Hospital in Mashhad
Full name of responsible person
Dr Sadegh Vahabi Amlashi
Street address
Ahmadabad St, Mashhad, GHaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
http://quaem.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Opposite to Daneshgah 18 St, Mashhad University of Medical Sciences, Deputy of Research and Technology of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php
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
Vahideh Saabeti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No B42, Kohansangi Residential Complex, Koohsangi 15 Ave, Koohsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9176774448
Phone
+98 51 3849 4720
Email
sabetiv@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr sadegh Vahabi Amlashi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
daneshgah st, Imam Reza hospital, Dermatology department
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51385430319
Email
VahabiS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahideh Sabeti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
NO B42, Kohansangi Residential Complex, Koohsangi15 Ave, Koohsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9176774448
Phone
+98 51 3849 4720
Email
sabetiv@yahoo.com
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
Not applicable
Data Dictionary
Not applicable
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 will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.