Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris

November 17, 2025 updated by: Hagar El Sayed, Cairo University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBUVB
Type of phototherapy
Device: NBUVB
Phototherapy device
Active Comparator: Medical treatment
combined oral itraconazole and terbinafine.
Drug: Itraconazole + terbinafine
Antifungal drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dermatophytosis Severity Score (DSS)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBUVB in resistant tinea

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fungal Resistance

Clinical Trials on NBUVB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe