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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.
Full 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.
Enrollment
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Inclusion criteria
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
Xeroderma pigmentosa, LE or other photosensitive dermatoses. dermatomyositis.
Other skin conditions (psoriasis, eczema, etc.).
Known autoimmune diseases, immunosuppression, or coagulopathies..
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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