Fungal Resistance
Conditions
Brief summary
This study aims to assess the efficacy of narrow-band ultraviolet B (NB-UVB) phototherapy as a standalone treatment in patients with resistant and recurrent tinea. To evaluate the clinical and mycological improvement in response to NB-UVB therapy compared to standard anti-fungal treatment alone.
Detailed description
Randomized, parallel-group, two-arm clinical trial. Arm A (NB-UVB group): Patients receive narrowband UVB phototherapy only. Arm B (Itraconazole + Terbinafine group): Patients receive combined oral itraconazole and terbinafine. Allocation will be 1:1 using concealed randomization. Intervention: Intervention (Arm A): Patients in Arm A will receive narrowband UVB phototherapy (311 nm) three times per week for a total of 8 weeks. Starting dose: 280-320 mJ/cm² (based on Fitzpatrick skin type) Dose escalation: Increase by 10-20% each week as tolerated, with weekly monitoring for erythema or other adverse effects. Follow-up: All Arm A patients will be re-evaluated clinically and mycologically 8 weeks after completing the 8-week NB-UVB course (i.e., at week 16 from baseline) to assess sustained response and relapse. Intervention (Arm B): Patients in Arm B will receive oral itraconazole plus terbinafine concurrently: Itraconazole: 200 mg once daily for 8 weeks Terbinafine: 250 mg once daily for 8 weeks Follow-up: All Arm B patients will be re-evaluated clinically and mycologically 8 weeks after completing the 8-week antifungal course (also at week 16 from baseline) to assess sustained response and relapse. Monitoring: Weekly observation for erythema or side effects. A follow-up period of 8 weeks after the end of treatment will be included to assess relapse and sustained clinical/mycological improvement.
Interventions
DEVICENBUVB
Phototherapy device
DRUGItraconazole + terbinafine
Antifungal drugs
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥18 years. Both sexes. Clinical diagnosis of tinea corporis or cruris. Failure of ≥4 weeks of systemic antifungal therapy (e.g., terbinafine or itraconazole). No antifungal (topical or systemic) or corticosteroid treatment in the 2 weeks preceding enrollment. Recurrent infection (≥2 relapses in the past 6 months) Positive KOH microscopy and culture at baseline
Exclusion criteria
* Photosensitivity disorders or photosensitizing medications. Xeroderma pigmentosa, LE or other photosensitive dermatoses. dermatomyositis. Other skin conditions (psoriasis, eczema, etc.). Known autoimmune diseases, immunosuppression, or coagulopathies..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermatophytosis Severity Score (DSS) | 8 weeks |
Outcome results
None listed