Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT07242703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D000077291', 'term': 'Terbinafine'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermatophytosis Severity Score (DSS)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fungal Resistance']}, 'descriptionModule': {'briefSummary': '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.\n\nTo evaluate the clinical and mycological improvement in response to NB-UVB therapy compared to standard anti-fungal treatment alone.', 'detailedDescription': 'Randomized, parallel-group, two-arm clinical trial. Arm A (NB-UVB group): Patients receive narrowband UVB phototherapy only.\n\nArm B (Itraconazole + Terbinafine group): Patients receive combined oral itraconazole and terbinafine.\n\nAllocation will be 1:1 using concealed randomization.\n\nIntervention:\n\nIntervention (Arm A):\n\nPatients in Arm A will receive narrowband UVB phototherapy (311 nm) three times per week for a total of 8 weeks.\n\nStarting dose: 280-320 mJ/cm² (based on Fitzpatrick skin type)\n\nDose escalation: Increase by 10-20% each week as tolerated, with weekly monitoring for erythema or other adverse effects.\n\nFollow-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.\n\nIntervention (Arm B):\n\nPatients in Arm B will receive oral itraconazole plus terbinafine concurrently:\n\nItraconazole: 200 mg once daily for 8 weeks\n\nTerbinafine: 250 mg once daily for 8 weeks\n\nFollow-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.\n\nMonitoring: Weekly observation for erythema or side effects.\n\nA follow-up period of 8 weeks after the end of treatment will be included to assess relapse and sustained clinical/mycological improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥18 years.\n\nBoth sexes.\n\nClinical diagnosis of tinea corporis or cruris.\n\nFailure of ≥4 weeks of systemic antifungal therapy (e.g., terbinafine or itraconazole).\n\nNo antifungal (topical or systemic) or corticosteroid treatment in the 2 weeks preceding enrollment.\n\nRecurrent infection (≥2 relapses in the past 6 months)\n\nPositive KOH microscopy and culture at baseline\n\nExclusion Criteria:\n\n* Photosensitivity disorders or photosensitizing medications.\n\nXeroderma pigmentosa, LE or other photosensitive dermatoses. dermatomyositis.\n\nOther skin conditions (psoriasis, eczema, etc.).\n\nKnown autoimmune diseases, immunosuppression, or coagulopathies..'}, 'identificationModule': {'nctId': 'NCT07242703', 'briefTitle': 'Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris', 'orgStudyIdInfo': {'id': 'NBUVB in resistant tinea'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBUVB', 'description': 'Type of phototherapy', 'interventionNames': ['Device: NBUVB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical treatment', 'description': 'combined oral itraconazole and terbinafine.', 'interventionNames': ['Drug: Itraconazole + terbinafine']}], 'interventions': [{'name': 'NBUVB', 'type': 'DEVICE', 'description': 'Phototherapy device', 'armGroupLabels': ['NBUVB']}, {'name': 'Itraconazole + terbinafine', 'type': 'DRUG', 'description': 'Antifungal drugs', 'armGroupLabels': ['Medical treatment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Hagar El Sayed Abd El Ghani Anter', 'investigatorFullName': 'Hagar El Sayed', 'investigatorAffiliation': 'Cairo University'}}}}