drugset / Trial / NCT07835438
Transdermal Versus Intralesional Betamethasone for Keloids
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the efficacy and safety of transdermal delivery of compound betamethasone using a medium-frequency device compared with intralesional injection in the treatment of keloids. A total of 45 patients will be enrolled and assigned in a 1:2 ratio to either the intralesional injection group or the transdermal delivery group. Participants will receive three treatment sessions over an 8-week period. Clinical outcomes will be assessed using the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and patient-reported outcomes at multiple follow-up time points up to 52 weeks. Safety will be evaluated through monitoring of adverse events, vital signs, and laboratory tests.
Timeline
- Start
- 2025-04-25
- Primary completion
- 2026-06-16
- Completion
- 2026-11-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BETAMETHASONE DIPROPIONATE | Small molecule | — | Other |