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:
Cairo University
Organization:
Study Overview
Official Title:
Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: