Fungal ResistanceNCT07242703
Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris
A study testing NBUVB and Itraconazole + terbinafine in people with Fungal Resistance, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Resistance
- What is being tested?
- NBUVB and Itraconazole + terbinafine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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..
About this study
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.
Read the 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.
- Conditions
- Fungal Resistance
- Being tested
- NBUVB, Itraconazole + terbinafine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBUVBDevice
Phototherapy device
Itraconazole + terbinafineDrug
Antifungal drugs
| Study group | Role | What they receive |
|---|---|---|
| NBUVB | Experimental | Type of phototherapy Receives: Device: NBUVB |
| Medical treatment | Active comparator | combined oral itraconazole and terbinafine. Receives: Drug: Itraconazole + terbinafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatophytosis Severity Score (DSS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal ResistanceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242703
- Sponsor's protocol ID
- NBUVB in resistant tinea
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris
- ClinicalTrials.gov ID
- NCT07242703
- Acronym / sponsor ID
- NBUVB in resistant tinea
- Conditions
- Fungal Resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBUVB | Experimental | Device: NBUVBType of phototherapy |
| Medical treatment | Active comparator | Drug: Itraconazole + terbinafinecombined oral itraconazole and terbinafine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBUVBPhototherapy device | Device | NBUVB |
| Itraconazole + terbinafineAntifungal drugs | Drug | Medical treatment |
Primary outcome
Dermatophytosis Severity Score (DSS)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NBUVB and Itraconazole + terbinafine in people with Fungal Resistance, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatophytosis Severity Score (DSS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.