drugset / Trial / NCT05710094
Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds
RandomizedParallel-groupTriple-blindTreatment
Summary
Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg wounds and of open-label once daily, twice daily, and thrice daily dosing of topically applied SBE for five days in patients with chronic leg wounds. The primary objective of the study is to assess the safety and tolerability of single and multiple doses of topically applied SBE in patients with chronic leg wounds. A secondary objective of the study is to assess changes in bacterial burden in the leg wound after treatment with SBE.
Timeline
- Start
- 2021-10-19
- Primary completion
- 2022-08-19
- Completion
- 2022-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SoftOx Biofilm Eradicator | Unknown | 1 % | Topical |
| Subject | SoftOx Biofilm Eradicator | Unknown | 2 % | Topical |
| Subject | SoftOx Biofilm Eradicator | Unknown | 3 % | Topical |
| Subject | SoftOx Biofilm Eradicator | Unknown | 500 ppm | Topical |
| Subject | SoftOx Biofilm Eradicator | Unknown | 1000 ppm | Topical |