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Comparison of the effectiveness of SLN containing finasteride and finasteride tablets in androgenic alopecia

Protocol summary

Study aim
Effect of topical SLN containing finasteride on androgenic alopecia
Design
Clinical trial with 25 controls and 25 intervention groups, parallel, single blind, randomized with random numbers table
Settings and conduct
Dermatology Clinic of Imam Reza Hospital Hospital (Mashhad University of Medical Sciences) Single blind: prescribe and drug evaluation is done by two different people. So that the evaluator does not know which patient is in which group. َAs the patient will find out whether the tablet can be taken or the solution, this study can not be considered as a double blind. The two groups, the first group, received topical 0.1% finasteride in the form of SLN with 5% localized minoxidil, and the second group received 5% minoxidil with finasteride 1 mg tablet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male patients aged 18-45 years with androgenic alopecia according to the Hamilton-Norwood criteria (Stages 2 to 4) Non-inclusion criteria: Iron supplements, iron deficiency anemia, thyroid and systemic diseases including lupus, Areata Alopecia, arthritis and and taking medications that cause hair loss, psychiatric illnesses, history of alcohol abuse or drug abuse, history of use of finasteride in the last 6 months, and minoxidil in one month In the past, patients with skeletal dysfunctions, seriously Cardiovascular, kidney, liver disease, history of hypersensitivity to medication, surgical history for the treatment of hair loss Exclusion criteria: Report of skin irritation, Failure to cooperate in the correct use of the drug and uncommon side effects of Finasteride
Intervention groups
The first group: topical 0.1% finasteride as SLN with 5% localized minoxidil the second group: 5% minoxidil with 1 mg finasteride tablet
Main outcome variables
The number, thickness and cumulative density of hair in the area of assessment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181128041780N1
Registration date: 2019-06-30, 1398/04/09
Registration timing: retrospective

Last update: 2019-06-30, 1398/04/09
Update count: 0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
shiva golmohammadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1323
Email address
golmohamadzadehsh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-30, 1397/09/09
Expected recruitment end date
2019-01-29, 1397/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of SLN containing finasteride and finasteride tablets in androgenic alopecia
Public title
Effect of SLN containing finasteride on anderogenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with Androgenic Alopecia Based on Hamilton's Criteria. Stage 2-4 Completing the consent form
Exclusion criteria:
No endocrine disease (diabetes), thyroid disorders, systemic diseases including lupus, other cases, including arthritis and cicatrisil (associated with scar), history of skin or systemic malignancy, psychiatric disorders, skin disorders Head skulls other than those with AGASerious Cardiovascular Diseases, Kidney Disease, Liver Disease No use of zinc and iron supplements, malnutrition, iron deficiency anemia Non-use of medications leads to hair loss, including anti-hypertensive and anti-inflammatory drugs, NSAIDs No history of alcohol consumption or substance abuse No history of finasteride in the last 6 months and minoxidil in the past month No history of drug hypersensitivity, breast disorders, surgical history for the treatment of hair loss
Age
From 18 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized random numbered table
Blinding (investigator's opinion)
Single blinded
Blinding description
Drug administration and drug evaluation are performed by two different individuals, so that the person evaluating is not aware of which patient is in the group.
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
2018-10-20, 1397/07/28
Ethics committee reference number
IR.MUMS.REC.1397.210

Health conditions studied

1

Description of health condition studied
anderogenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia

Primary outcomes

1

Description
The number of hair from short hair in 1 cm square in the area of assessment in the Vertex hairless part
Timepoint
At the beginning of the work and weeks 8, 16 and 24
Method of measurement
Using the computer scan obtained from macrophotography images of the marked area, it is evaluated for hair growth.

Secondary outcomes

1

Description
1- Evaluation of the frequency of local skin complications including: erythema-burning-itchy-folliculitis-clinical diagnosis by the assessor
Timepoint
At the beginning of the work and weeks 8, 16 and 24
Method of measurement
1-Measuring erythema and itching and burning with a visual analogue scale and evaluating folliculitis clinically and by assessor.

2

Description
2. Quality of life assessment
Timepoint
At the beginning of the work and weeks 8, 16 and 24
Method of measurement
2. Assessing the quality of life ,the basis of the WAA-QOL benchmark.

Intervention groups

1

Description
Intervention group: In the first group, 5% localized minoxidil twice a day, any time 1 cc with a 0.1% finasteride topical form, as SLN, once a day, any time 1 cc.
Category
Treatment - Drugs

2

Description
Control group: The topical solution of minoxidil 5% is given twice daily, any time 1 cc, with one tablet of finasteride 1 mg per day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic, Imam Raza Hospital
Full name of responsible person
sama gharaei
Street address
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2020
Email
gharaeis941@mums.ac.ir

2

Recruitment center
Name of recruitment center
Dermatology clinic,ghaem hospital
Full name of responsible person
sama gharaei
Street address
Ahmadabad street, beside the Parastar street
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-451
Phone
+98 51 3840 0000
Email
gharaeis941@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
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
sama gharaei
Position
student of pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
blv vakilabad ferdowsi university, faculty of pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3882 3255
Email
gharaeis941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr shiva golmohamadzadeh
Position
Professor of pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
blv vakilabad, university of ferdowsi , faculty of pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3882 3255
Email
Golmohamadzadehsh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr shiva golmohamdzadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
blv vakilabad ferdowsi univesrity
City
Mashhad
Province
Razavi Khorasan
Postal code
9171948954
Phone
+98 51 3882 3255
Email
golmohamadzadehsh@mums.ac.ir

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
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