Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000004369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/09/2025
Date registered
Help: Date registered
6/01/2026
Date last updated
Help: Date last updated
6/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/01/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing two medications (itraconazole and isotretinoin) in treating fungal infection.
Scientific title
Comparison of the efficacy of oral itraconazole alone versus combination of oral itraconazole with isotretinoin in treatment of tinea infection
Additional trial identifiers [1] 315244 0
nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Tinea infection 338768 0
Condition category
Condition code
Skin 335062 335062 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Group B : daily dose of oral Itraconazole 200mg together with 20mg/day of oral isotretinoin for duration of 8 weeks.
Intervention code [1] 331903 0
Treatment: Drugs
Description of the comparator or control
Group A : oral itraconazole 200mg once daily for a duration of 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 342690 0
The proportion of patients gaining complete clinical and mycological cure, as determine by total disappearance of symptoms and lesions along with negative 10% KOH preparation test in both categories at the completion of their 8-week therapy . The primary outcome is assessed by complete clinical and complete mycological cure
Timepoint [1] 342690 0
Baseline (week 0), 4 weeks and 8 weeks after commencing dosages (primary timepoint) and photographic clearance of lesions.
Secondary outcome [1] 451842 0
Safety evaluations will be done on monthly visits by asking patients about any adverse effects related to medications eg; dryness of skin, elevated liver enzymes, deranged lipid profile, gastrointestinal symptoms like nausea and vomiting
Timepoint [1] 451842 0
Baseline, 4 weeks and 8 weeks after commencing dosages.

Eligibility
Key inclusion criteria
• Tinea infection [confirmed on the basis of clinical findings having itchy, erythematous and scaly skin lesions with advancing borders along with a positive 10 % KOH (potassium hydroxide) preparation test for direct microscopic examination showing fungal hyphal filaments.]
• Patients with tinea faciei, corporis, cruris or tinea manuum and pedis.
• Age between 18-75 years.
• Patients of both genders
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Patients with tinea capitis and onychomycosis.
• Patients with renal and chronic liver diseases.
• Patients with coronary heart diseases and hyperlipidemia.
• Patients with uncontrolled diabetes mellitus.
• Patients with uncontrolled hypertension.
• Those on chronic immunosuppressive therapy.
• Pregnant and lactating women.
• Elderly patients (>75 YEARS)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2025
Date of last participant enrolment
Anticipated
Actual
30/11/2025
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
94
Accrual to date
Final
94
Recruitment outside Australia
Country [1] 27331 0
Pakistan
State/province [1] 27331 0

Funding & Sponsors
Funding source category [1] 319810 0
Hospital
Name [1] 319810 0
PAKISTAN NAVAL SHIP SHIFA HOSPITAL,KARACHI
Country [1] 319810 0
Pakistan
Primary sponsor type
Hospital
Name
PAKISTAN NAVAL SHIP SHIFA HOSPITAL,KARACHI
Address
Country
Pakistan
Secondary sponsor category [1] 322326 0
None
Name [1] 322326 0
Address [1] 322326 0
Country [1] 322326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318366 0
Ethical review committee, PNS Shifa Hospital Karachi
Ethics committee address [1] 318366 0
Ethics committee country [1] 318366 0
Pakistan
Date submitted for ethics approval [1] 318366 0
04/11/2024
Approval date [1] 318366 0
11/12/2024
Ethics approval number [1] 318366 0

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

Contacts
Principal investigator
Name 143962 0
Dr Naima Saghir
Address 143962 0
Pakistan Naval Ship Shifa Hospital, Defence 2 Karachi Sindh, postal code 07557
Country 143962 0
Pakistan
Phone 143962 0
+923323246321
Fax 143962 0
Email 143962 0
[email protected]
Contact person for public queries
Name 143963 0
Naima Saghir
Address 143963 0
Pakistan Naval Ship Shifa Hospital, Defence 2 Karachi Sindh, postal code 07557
Country 143963 0
Pakistan
Phone 143963 0
+923323246321
Fax 143963 0
Email 143963 0
[email protected]
Contact person for scientific queries
Name 143964 0
Dr Atiya Rahman
Address 143964 0
Pakistan Naval Ship Shifa Hospital, Defence 2 Karachi Sindh, postal code 07557
Country 143964 0
Pakistan
Phone 143964 0
+923345252383
Fax 143964 0
Email 143964 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] Ethical approval form.pdf
Informed consent form  [email protected] consent form.docx


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.