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Seborrheic DermatitisPhase 4NCT07906886

Topical Terbinafine Versus Hydrocortisone Combined With Oral Itraconazole for Seborrheic Dermatitis

A Phase 4 study testing Itraconazole, Terbinafine 1% cream and Hydrocortisone 1% cream in people with Seborrheic Dermatitis, run by Can Tho University of Medicine and Pharmacy at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Seborrheic Dermatitis
What is being tested?
Itraconazole, Terbinafine 1% cream and Hydrocortisone 1% cream
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesVietnam
Study dates
7 Jul 2025to 13 Oct 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of seborrheic dermatitis according to the Diagnostic and Treatment Guidelines of the Vietnamese Ministry of Health (Decision No. 4416/QD-BYT, 2023): white, fine scales or greasy erythematous plaques with yellowish scales in seborrheic areas, with or without itching or burning
  • Age 18 years or older
  • Moderate or severe disease (SDASI 4.5 or higher)
  • Written informed consent

Who cannot join

  • Concomitant skin disease (atopic dermatitis, psoriasis, contact dermatitis)
  • Known allergy to any study drug
  • Chronic or active liver disease
  • Use of topical antifungals, corticosteroids or calcineurin inhibitors within 2 weeks before enrolment
  • Use of systemic antifungals or corticosteroids within 4 weeks before enrolment
  • Pregnancy or breastfeeding
  • Current use of drugs interacting with itraconazole (cyclosporine, isoniazid, antacids, proton-pump inhibitors, H2-receptor antagonists, warfarin, statins)

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • Can Tho Dermatology Hospital

    Can Tho

  • Can Tho University of Medicine and Pharmacy Hospital

    Can Tho

Other trials in Vietnam

About this study

Official title: Topical Terbinafine 1% Versus Hydrocortisone 1% Combined With Oral Itraconazole for Moderate-to-Severe Seborrheic Dermatitis: A Two-Centre Non-Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
Itraconazole, Terbinafine 1% cream, Hydrocortisone 1% cream
Keywords
Itraconazole, Terbinafine, Hydrocortisone, Antifungal Agents, Topical corticosteroid
Medical subject headings
Dermatitis, Seborrheic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItraconazoleDrug

    100 mg orally twice daily for 14 days.

  • Terbinafine 1% creamDrug

    Applied to all affected areas twice daily (morning and evening) for 28 days, starting on the same day as itraconazole.

  • Hydrocortisone 1% creamDrug

    Applied to all affected areas twice daily (morning and evening) for 28 days, starting on the same day as itraconazole.

Study groups in NCT07906886
Study groupRoleWhat they receive
Terbinafine 1% cream + oral itraconazoleExperimentalOral itraconazole 100 mg twice daily for 14 days plus terbinafine 1% cream applied to all affected areas twice daily for 28 days.
Receives: Drug: Itraconazole; Drug: Terbinafine 1% cream
Hydrocortisone 1% cream + oral itraconazoleActive comparatorOral itraconazole 100 mg twice daily for 14 days plus hydrocortisone 1% cream applied to all affected areas twice daily for 28 days.
Receives: Drug: Itraconazole; Drug: Hydrocortisone 1% cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 2 (end of oral itraconazole)

Secondary outcomes (6)

  1. SDASI score at end of topical treatment

    Three-component SDASI (range 0-12.6); higher scores indicate more severe disease.

    Measured: Week 4

  2. 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.

    Measured: Week 2 and week 4

  3. Clinical response category

    Complete clearance (SDASI = 0); marked improvement (≥50% reduction); slight improvement (1-49% reduction); no improvement (no reduction or worsening).

    Measured: Week 2 and week 4

  4. Itching score

    Patient-rated global itching on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

    Measured: Baseline, week 2 and week 4

  5. Burning score

    Patient-rated global burning on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

    Measured: Baseline, week 2 and week 4

  6. 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.

    Measured: Week 2 and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start7 Jul 2025
  3. Primary completion13 Oct 2026
  4. Study completion13 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Two parallel groups: terbinafine 1% cream or hydrocortisone 1% cream, each combined with oral itraconazole.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07906886
Sponsor's protocol ID
25.085.HV/PCT-HĐĐĐ-ĐC
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the article will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Itraconazole, Terbinafine 1% cream and Hydrocortisone 1% cream in people with Seborrheic Dermatitis, run by Can Tho University of Medicine and Pharmacy at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seborrheic Dermatitis Area and Severity Index (SDASI) score (time frame: Week 2 (end of oral itraconazole)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07906886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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