Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000021370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/09/2025
Date registered
Help: Date registered
7/01/2026
Date last updated
Help: Date last updated
7/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/01/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing two medicines (Itraconazole and Isotretinion) in treating seborrheic dermatitis
Scientific title
Comparison of the effect of low-dose oral Isotretinoin and Itraconazole on symptoms in seborrheic dermatitis
Additional trial identifiers [1] 315228 0
nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Seborrheic Dermatitis 338713 0
Condition category
Condition code
Skin 335850 335850 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Group A: Low-Dose Oral Isotretinoin (20 mg/day twice weekly for three consecutive months)
Intervention code [1] 331869 0
Treatment: Drugs
Description of the comparator or control
Group B: oral Itraconazole (200 mg/day during the 1st week of the 1st month, then 200 mg daily on 1st two days of every month for next two months), for total of 3 months.
Control group
Active

Outcomes
Primary outcome [1] 342640 0
o Complete Resolution of symptoms (90% Decrease or more of SDASI Score from Baseline) o Partial Improvement of symptoms(25-90% Decrease in SDASI Score from Baseline) o No Improvement of symptoms (< 25% Decrease in SDASI Score from Baseline) and no serious drug related adverse affect yes this is a composite primary outcome
Timepoint [1] 342640 0
At Baseline,4 weeks,8 weeks and 12 weeks after commencing dosage
Secondary outcome [1] 451641 0
Safety evaluations will be done on monthly visits by asking patients about any adverse effects related to medication, eg; dryness of skin ,elevated liver enzymes, deranged lipid profile or any gastrointestinal upsets
Timepoint [1] 451641 0
Baseline,4 weeks,8 weeks and 12 weeks after commencing dosage

Eligibility
Key inclusion criteria
• Both Genders
• Adults aged 18–70 years.
• Clinical assessment using the SDASI (Seborrheic Dermatitis Area Severity Index),of moderate to severe Seborrheic dermatitis (a score of 4 and above).
• Agreeing to follow the instructions given in the course of the study and show up for follow-up examinations.
• Patients not taking any topical medication for Seborrheic Dermatitis for the last two months
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Pregnant or breastfeeding women.
• Current use of systemic antifungals, or isotretinoin within the past half a year.
• Patients with any history of Hyperlipidemia, severe hepatic, renal or cardiac disease.
• Patients known to be hypersensitive to isotretinoin and itraconazole.
• Patients with uncontrolled Diabetes Mellitus, Malnourished, children or those receiving systemic immunosuppressants.
• Patients having mild Seborrheic Dermatitis

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
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2025
Date of last participant enrolment
Anticipated
Actual
30/09/2025
Date of last data collection
Anticipated
Actual
30/12/2025
Sample size
Target
68
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 27327 0
Pakistan
State/province [1] 27327 0

Funding & Sponsors
Funding source category [1] 319794 0
Hospital
Name [1] 319794 0
PAKISTAN NAVAL SHIP SHIFA HOSPITAL,KARACHI
Country [1] 319794 0
Pakistan
Primary sponsor type
Hospital
Name
PNS SHIFA HOSPITAL
Address
Country
Pakistan
Secondary sponsor category [1] 322353 0
None
Name [1] 322353 0
Address [1] 322353 0
Country [1] 322353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318353 0
Ethical review committee,PNS Shifa Hospital Karachi
Ethics committee address [1] 318353 0
Ethics committee country [1] 318353 0
Pakistan
Date submitted for ethics approval [1] 318353 0
01/04/2024
Approval date [1] 318353 0
13/05/2024
Ethics approval number [1] 318353 0

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

Contacts
Principal investigator
Name 143910 0
Dr Sidra Anwer
Address 143910 0
Pakistan Naval Ship Shifa hospital,Defence 2 Karachi,Sindh, post code 07557
Country 143910 0
Pakistan
Phone 143910 0
+923423384643
Fax 143910 0
Email 143910 0
[email protected]
Contact person for public queries
Name 143911 0
Sidra Anwer
Address 143911 0
Pakistan Naval Ship Shifa hospital,Defence 2 Karachi,Sindh, post code 07557
Country 143911 0
Pakistan
Phone 143911 0
+923423384643
Fax 143911 0
Email 143911 0
[email protected]
Contact person for scientific queries
Name 143912 0
Dr Atiya Rahman
Address 143912 0
Pakistan Naval Ship Shifa hospital,Defence 2, Karachi ,Sindh,post code 07557
Country 143912 0
Pakistan
Phone 143912 0
+923345252383
Fax 143912 0
Email 143912 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] Synopsis- Ethical Approval.pdf
Informed consent form  [email protected] consent form.pdf


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.