Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000611426
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dual therapy with minocycline and itraconazole in the treatment of superficial fungal infections
Scientific title
Dual therapy with minocycline and itraconazole in the treatment of resistant dermatophytosis : double blind therapeutic comparative case - control study in participants with recurrent dermatophytosis
Secondary ID [1] 313213 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fungal infection of skin 335513 0
Condition category
Condition code
Skin 332071 332071 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The case group : receive minocycline tablet 80 mg orally once daily in addition to itraconazole capsule 100 mg orally once daily for 4 to 6 weeks
The strategy that used to monitor adherence to the intervention is drug tablet return
The group allocation is determined by physician discretion ? in form that the first 10 participants receive control , next 10 receive intervention , etc
Intervention code [1] 329787 0
Treatment: Drugs
Comparator / control treatment

The control group : receive itraconazole capsule 100 mg orally once daily for 4 to 6 weeks
Control group
Active

Outcomes
Primary outcome [1] 339670 0
The primary outcome is change in dermatophyte infection that assessed clinically by itching , scale and erythema and also by dermoscopic examination
Timepoint [1] 339670 0
Follow up period at 2 , 4 , 6 weeks post intervention commencement
Secondary outcome [1] 440821 0
The adverse effect of itraconazole and minocycline
Timepoint [1] 440821 0
At 2, 4, 6 weeks post intervention commencement

Eligibility
Key inclusion criteria
All pateints with recurrent dermatophytosis
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with chronic liver and renal diseases, congested heart failure or any chronic heart diseases, pregnant and lactating women, patients with known allergies to both used drugs, poor compliance patients and children below 18, and patients older than 65 years old,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/02/2024
Date of last participant enrolment
Anticipated
Actual
1/02/2025
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
240
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 26640 0
Iraq
State/province [1] 26640 0
Basrah

Funding & Sponsors
Funding source category [1] 317658 0
Self funded/Unfunded
Name [1] 317658 0
Sura faisal Abdullah / funding the study from their own personal funds . Works at alsader teaching hospital
Country [1] 317658 0
Iraq
Primary sponsor type
Individual
Name
Duha khaleel Ismail / Al sader teaching hospital - Basrah
Address
Country
Iraq
Secondary sponsor category [1] 319971 0
Individual
Name [1] 319971 0
Sura faisal Abdullah / Al sader teaching hospital - Basrah
Address [1] 319971 0
Country [1] 319971 0
Iraq

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316356 0
the Scientific Council of Dermatology & Venereology-Iraqi Board for Medical Specializations.
Ethics committee address [1] 316356 0
Ethics committee country [1] 316356 0
Iraq
Date submitted for ethics approval [1] 316356 0
20/11/2023
Approval date [1] 316356 0
02/01/2024
Ethics approval number [1] 316356 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137630 0
Dr Sura faisal Abdullah
Address 137630 0
Al - Sader teaching hospital / Al buradhia, GV42+Q6F, Basrah, Basra Governorate, Iraq
Country 137630 0
Iraq
Phone 137630 0
+9647702934503
Fax 137630 0
Email 137630 0
[email protected]
Contact person for public queries
Name 137631 0
Sura faisal Abdullah
Address 137631 0
Al - Sader teaching hospital / Al buradhia, GV42+Q6F, Basrah, Basra Governorate, Iraq
Country 137631 0
Iraq
Phone 137631 0
+9647702934503
Fax 137631 0
Email 137631 0
[email protected]
Contact person for scientific queries
Name 137632 0
Sura faisal Abdullah
Address 137632 0
Al - Sader teaching hospital / Al buradhia, GV42+Q6F, Basrah, Basra Governorate, Iraq
Country 137632 0
Iraq
Phone 137632 0
+9647702934503
Fax 137632 0
Email 137632 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.