drugset / Trial / NCT04956900
Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (VLU)
Timeline
- Start
- 2021-08-09
- Primary completion
- 2023-02-06
- Completion
- 2023-02-06
Outcome
Met primary endpoint
release “SolasCure’s CLEANVLU Phase IIa clinical trial met its primary endpoint; a successful evaluation of safety with no evidence of systemic absorption” solascure.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aurase | Protein / enzyme biologic | — | Topical |