drugset / Trial / NCT07835438

Transdermal Versus Intralesional Betamethasone for Keloids

NCT07835438 ↗

Active not recruiting 45 enrolled First Hospital of China Medical University
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

EvaluationDrugModalityDoseRoute
Subject BETAMETHASONE DIPROPIONATE Small molecule — Other

Indications