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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fungal Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NBUVB

Type of phototherapy

Group Type EXPERIMENTAL

NBUVB

Intervention Type DEVICE

Phototherapy device

Medical treatment

combined oral itraconazole and terbinafine.

Group Type ACTIVE_COMPARATOR

Itraconazole + terbinafine

Intervention Type DRUG

Antifungal drugs

Interventions

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NBUVB

Phototherapy device

Intervention Type DEVICE

Itraconazole + terbinafine

Antifungal drugs

Intervention Type DRUG

Eligibility Criteria

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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..
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hagar El Sayed

Dr Hagar El Sayed Abd El Ghani Anter

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NBUVB in resistant tinea

Identifier Type: -

Identifier Source: org_study_id

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