Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris
NCT ID: NCT07242703
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-12-01
2026-05-01
Brief Summary
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To evaluate the clinical and mycological improvement in response to NB-UVB therapy compared to standard anti-fungal treatment alone.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NBUVB
Type of phototherapy
NBUVB
Phototherapy device
Medical treatment
combined oral itraconazole and terbinafine.
Itraconazole + terbinafine
Antifungal drugs
Interventions
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NBUVB
Phototherapy device
Itraconazole + terbinafine
Antifungal drugs
Eligibility Criteria
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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..
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Hagar El Sayed
Dr Hagar El Sayed Abd El Ghani Anter
Other Identifiers
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NBUVB in resistant tinea
Identifier Type: -
Identifier Source: org_study_id
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