drugset / Trial / NCT07237425
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
RandomizedSequentialQuadruple-blindTreatment
Summary
This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for evaluating its relative bioavailability in comparison to an FDA-approved lipolysis injection, Kybella.
Timeline
- Start
- 2025-11-14
- Primary completion
- 2028-05-31
- Completion
- 2028-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Deoxycholic Acid | Unknown | 100 mg | — |
| Subject | Kybella | Unknown | 0.25 ml | Other |
| Subject | Kybella | Unknown | 0.5 ml | Other |
| Subject | Kybella | Unknown | 0.75 ml | Other |
| Subject | Kybella | Unknown | 1 ml | Other |