Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT07242703
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.
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:
NCT07242703
Study Brief:
Protocol Section:
NCT07242703