Seborrheic Dermatitis
Conditions
Keywords
Itraconazole, Terbinafine, Hydrocortisone, Antifungal Agents, Topical corticosteroid
Brief 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 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.
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.
Interventions
DRUGItraconazole
100 mg orally twice daily for 14 days.
DRUGTerbinafine 1% cream
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.
Sponsors
Can Tho University of Medicine and Pharmacy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
SDASI was scored by a single trained investigator before checking the patient's group assignment. Participants were not masked.
Intervention model description
Two parallel groups: terbinafine 1% cream or hydrocortisone 1% cream, each combined with oral itraconazole.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seborrheic Dermatitis Area and Severity Index (SDASI) score | Week 2 (end of oral itraconazole) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SDASI score at end of topical treatment | Week 4 | Three-component SDASI (range 0-12.6); higher scores indicate more severe disease. |
| Proportion of patients with ≥50% reduction in SDASI from baseline | Week 2 and week 4 | Number of patients achieving at least a 50% reduction in SDASI score compared with baseline. |
| Clinical response category | Week 2 and week 4 | Complete clearance (SDASI = 0); marked improvement (≥50% reduction); slight improvement (1-49% reduction); no improvement (no reduction or worsening). |
| Itching score | Baseline, week 2 and week 4 | Patient-rated global itching on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). |
| Burning score | Baseline, week 2 and week 4 | Patient-rated global burning on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). |
| Number of patients with local adverse events at the application site | Week 2 and week 4 | Erythema, itching, rash or swelling/pain at the application site, recorded on a checklist at each follow-up visit. |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORGia Hung Tran, MD, PhD
Can Tho University of Medicine and Pharmacy
STUDY_DIRECTORDang Khoa Dang Tran, MD
Can Tho University of Medicine and Pharmacy
Outcome results
None listed