A Phase 4 interventional study of Itraconazole and Terbinafine 1% cream in Seborrheic Dermatitis, sponsored by Can Tho University of Medicine and Pharmacy. Completed at 2 sites in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Can Tho University of Medicine and Pharmacy · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to compare two creams used together with oral itraconazole in adults with moderate-to-severe seborrheic dermatitis. The main question it aims to answer is: does terbinafine 1% cream give lower disease severity than hydrocortisone 1% cream at the end of a 2-week course of oral itraconazole?
Participants took oral itraconazole 100 mg twice daily for 2 weeks and applied either terbinafine 1% cream or hydrocortisone 1% cream twice daily for 4 weeks. Disease severity (Seborrheic Dermatitis Area and Severity Index, SDASI), itching, burning and local side effects were assessed at baseline, week 2 and week 4.
This was a two-centre, parallel-group, open-label controlled trial with non-random allocation, conducted at Can Tho University of Medicine and Pharmacy Hospital and Can Tho Dermatology Hospital, Can Tho, Vietnam. Adults with seborrheic dermatitis and SDASI ≥4.5 were assigned to two groups by a predefined fixed sequence (1, 2, 2, 1) according to order of enrolment at each hospital. Both groups received oral itraconazole 100 mg twice daily for 14 days; group 1 applied terbinafine 1% cream and group 2 applied hydrocortisone 1% cream twice daily for 28 days. SDASI was scored by a single trained investigator before checking group assignment. The primary outcome was SDASI at week 2, analysed by analysis of covariance adjusted for baseline SDASI and study site. Secondary outcomes were SDASI at week 4, the proportion of patients with ≥50% reduction in SDASI, itching and burning scores, and local adverse events.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's enrollment of 76 is close to the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral itraconazole 100 mg twice daily for 14 days plus terbinafine 1% cream applied to all affected areas twice daily for 28 days.
Drug: Itraconazole · Drug: Terbinafine 1% cream
Oral itraconazole 100 mg twice daily for 14 days plus hydrocortisone 1% cream applied to all affected areas twice daily for 28 days.
Drug: Itraconazole · Drug: Hydrocortisone 1% cream
100 mg orally twice daily for 14 days.
Applied to all affected areas twice daily (morning and evening) for 28 days, starting on the same day as itraconazole.
Applied to all affected areas twice daily (morning and evening) for 28 days, starting on the same day as itraconazole.
Seborrheic Dermatitis Area and Severity Index (SDASI) score
Three-component SDASI (erythema, scaling and itching, each graded 0-3), weighted by area; range 0-12.6, higher scores indicate more severe disease. Scored by a single trained investigator before checking group assignment.
Time frame: Week 2 (end of oral itraconazole)
SDASI score at end of topical treatment
Three-component SDASI (range 0-12.6); higher scores indicate more severe disease.
Time frame: Week 4
Proportion of patients with ≥50% reduction in SDASI from baseline
Number of patients achieving at least a 50% reduction in SDASI score compared with baseline.
Time frame: Week 2 and week 4
Clinical response category
Complete clearance (SDASI = 0); marked improvement (≥50% reduction); slight improvement (1-49% reduction); no improvement (no reduction or worsening).
Time frame: Week 2 and week 4
Itching score
Patient-rated global itching on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: Baseline, week 2 and week 4
Burning score
Patient-rated global burning on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: Baseline, week 2 and week 4
Number of patients with local adverse events at the application site
Erythema, itching, rash or swelling/pain at the application site, recorded on a checklist at each follow-up visit.
Time frame: Week 2 and week 4
Plan to share: Yes — De-identified individual participant data underlying the results reported in the article will be shared.
Time frame: Beginning after publication of the article.
Access criteria: Available from the corresponding author (Tran Gia Hung, tghung@ctump.edu.vn) upon reasonable request.
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Oct 2026, 15 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terbinafine
Can Tho University of Medicine and Pharmacy