Main objective:
Investigating the effect of retinoid drug called isotretinoin along with azole subgroup drug called itraconazole in the treatment of patients diagnosed with skin fungus
Secondary objective:
Investigating the effect of isotretinoin along with itraconazole in the treatment of patients with skin fungus in relation to age / gender / the duration of the onset of the disease
Investigating the effect of isotretinoin along with itraconazole in the treatment of patients with skin fungus according to the size of the lesions and the location of the lesion
Design
The clinical trial has a control group, a blinded, randomized, phase 3 on 80 patients.
The random allocation of patients is done through the block randomization method, and a table of random numbers is used to prepare a random list
Settings and conduct
Patients are evaluated before the intervention, 1 month later, 2 months later, 3 months later and one month after the end of the intervention based on the criteria stated by the specialist.
Participants/Inclusion and exclusion criteria
80 patients diagnosed with dermatophyte by KOH test (potassium hydroxide, the solution in the test) will be included in the study after obtaining informed consent
People with immune deficiency and people with kidney and liver problems, diabetes, history of alcohol consumption, less than 12 and more than 60 years old, and pregnant and lactating women will be excluded from the study
Intervention groups
Patients will be randomly divided into two groups of 40 people
The control group (which will receive itraconazole at a dose of 200 mg daily) and the experimental group will be treated with a combination of itraconazole (at a dose of 100 mg twice a day) and isotretinoin (at a dose of 20 mg once a day)
Main outcome variables
Response to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240527061914N1
Registration date:2025-02-13, 1403/11/25
Registration timing:registered_while_recruiting
Last update:2025-02-13, 1403/11/25
Update count:0
Registration date
2025-02-13, 1403/11/25
Registrant information
Name
Hajar Masoomi farahabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 8863
Email address
saramasoomi1376@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-12, 1403/09/22
Expected recruitment end date
2025-08-12, 1404/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of isotretinoin along with itraconazole in the treatment of patients with dermatophytes
Public title
Investigating the effect of isotretinoin along with itraconazole in the treatment of skin fungus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with dermatophyte by Koh test
Exclusion criteria:
Under 12 years
Over 60 years old
pregnant
milked
Has a history of diabetes
Has a history of liver disease
Has a history of kidney disease
History of alcohol consumption
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
The table of random numbers is used in such a way that a random number is generated at each stage. If the generated number is between 0 and 4, the patient is placed in the Isotretinoin and Itraconazole group, and if the number is between 5 and 9, the patient is placed in the Itraconazole group. Therefore, we repeat this process many times until eligible patients enter the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Two groups of 40 people with dermatophytes are randomly treated with antifungal.
The method of blinding is single blind, which means that the patient does not know the type of treatment (before starting the treatment, the patients will be ethically discussed and they will enter the study with full consent and knowledge).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Fatemeh Saeidi
Street address
Keshavarz Blvd., Intersection of Qods St., Central Building of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.328
Health conditions studied
1
Description of health condition studied
Dermatophyte (fungal disease)
ICD-10 code
B35.4
ICD-10 code description
Tinea corporis
Primary outcomes
1
Description
Comparison of the effect of isotretinoin on the treatment of dermatophytes
Timepoint
Examination at the beginning of the study and then monthly until the dermatophyte infection is completely resolved
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treated with itraconazole 100 mg every 12 hours and isotretinoin 20 mg every other day and sertaconazole ointment every 8 hours and shampoo ketoconazole 3 times a week
Category
Treatment - Drugs
2
Description
Control group: treated with itraconazole 100 mg every 12 hours and sertaconazole ointment every 8 hours and shampoo ketoconazole 3 times a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Hajar Masoomi Farahabadi
Street address
Vahdat eslami street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 911 329 0091
Fax
+98 911 329 0091
Email
saramasoomi1376@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Ali Akbari Sari
Street address
Tehran - Vahdat Eslami St. - Razi Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 911 329 0091
Email
saramasoomi1376@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hajar Masoomi Farah abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Vesal Shirazi Street - between Italy Street and Parisi Ancient Alley - Vesal Hostel
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 911 329 0091
Email
saramasoomi1376@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. safoura shakoei nezhad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Islamic St. - Razi Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 912 322 0757
Email
dr.shakoei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hajar Massomi Farahabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Vesal Shirazi - between Italy Street and the ancient alley of Parisi - Vesal dormitory
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 911 329 0091
Email
saramasoomi1376@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The data will be provided to other researchers upon request
When the data will become available and for how long
It can be used after completing the study and statistical analysis and after the article is published
To whom data/document is available
researchers
Under which criteria data/document could be used
It can be used after the study and statistical analysis is completed and after the article is published
From where data/document is obtainable
Mrs. Dr. Saffora Shekoi Nejad
Mrs. Dr. Hajar Masoumi
Mr. Dr. Taha Shahbazi
Mr. Dr. Alireza Banani
What processes are involved for a request to access data/document