Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds

NCT05710094 | Completed Phase 1 DMC

• 1 other identifier: SBE-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Leg Ulcer; Venous Leg Ulcer

Keywords

lower extremities infection biofilm antimicrobial

Outcome Measures

Primary Outcomes (2)

• Nature, occurrence, and severity of adverse events (AEs)

  Clinically significant abnormal values of vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature), safety blood and urine parameters, ECG, and physical examination will be reported as AEs.

  From the start of the first administration of IMP to 3 to 5 days after the last administration of IMP

• Change from baseline in wound pain assessed by use of visual analogue scale (VAS).

  Change from baseline i.e., the last value before the (first) administration of IMP, in wound pain as assessed by use of a 10 cm VAS, where 0 cm indicated no pain at all, and 10 cm indicated the worst imaginable pain at the time of assessment.

  From the start of the first administration of IMP to 3 to 5 days after the last administration of IMP

Secondary Outcomes (1)

• Change from baseline in wound bacterial burden (number of colony-forming units per mL; CFU/mL)

  From the start of the first administration of IMP to 3 to 5 days after the last administration of IMP

Other Outcomes (1)

• Change from baseline in wound area

  From the start of the first administration of IMP to 3 to 5 days after the last administration of IMP

Study Arms (7)

Group 1

EXPERIMENTAL

Single dose of 500ppm HOCl + 1 % HAc, or placebo

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7); Device: Sterile isotonic saline (Groups 1 to 4)

Group 2

EXPERIMENTAL

Single dose of 500ppm HOCl + 2 % HAc, or placebo

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7); Device: Sterile isotonic saline (Groups 1 to 4)

Group 3

EXPERIMENTAL

Single dose of 500ppm HOCl + 3 % HAc, or placebo

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7); Device: Sterile isotonic saline (Groups 1 to 4)

Group 4

EXPERIMENTAL

Single dose of 1000ppm HOCl + 3 % HAc, or placebo

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7); Device: Sterile isotonic saline (Groups 1 to 4)

Group 5

EXPERIMENTAL

Multiple doses (OD for 5 days) of xppm HOCl + x% HAc#

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7)

Group 6

EXPERIMENTAL

Multiple doses (BID for 5 days) of xppm HOCl + x% HAc#

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7)

Group 7

EXPERIMENTAL

Multiple doses (TID for 5 days) of xppm HOCl + x% HAc#

Drug: SoftOx Biofilm Eradicator (Groups 1 to 7)

Interventions

SoftOx Biofilm Eradicator (Groups 1 to 7) DRUG

SBE is a water-based formulation containing hypochlorous acid (HOCl) at concentrations of 500-1000 µg/mL and acetic acid (HAc) at concentrations of 1-3 %. Both active ingredients are naturally occurring molecules and have a long history of safe use in medicinal products and in solutions approved as medical devices. Both molecules, exhibit broad-spectrum antimicrobial activity at the concentrations present in SBE. The antimicrobial effect of HOCl is rapid and powerful by acting on and disrupting the function of key microbial molecules such as proteins, lipids, and nucleic acids, while remaining safe to mammalian cells and not promoting the emergence of new resistant microbes. Moreover, HOCl is active against biofilms, and some studies suggest that HOCl may also increase oxygenation of the wound site leading to improved healing.

Also known as: SS0350

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7

Sterile isotonic saline (Groups 1 to 4) DEVICE

Sterile isotonic saline was used as placebo because it is part of standard of care, used as an irrigation solution at dressing change and has the same appearance as SBE

Also known as: Irriflex

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for this study, patients must fulfil all of the following criteria:
• Male and female patients aged 18 and above at time of informed consent.
• Chronic (present for at least 4 weeks) leg wound, as judged by the Investigator, with a size of at least 1 cm2 and maximally 100 cm2 (measured as the width x length) on the day of the (first) administration of IMP.
• Patients must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.

You may not qualify if:

• Any surgical or medical condition, including findings in the medical history or in the pre-study assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct, or evaluation at screening or time of the (first) administration of IMP.
• Known or clinical suspicion of cancer in the leg wound at screening or time of the (first) administration of IMP, e.g., basal cell carcinoma or squamous cell carcinoma.
• Clinical symptoms of COVID-19 or positive test for SARS-CoV-2 (testing according to local procedures) at screening or on the day of the (first) administration of IMP.
• Clinical infection requiring systemic antibiotics at time of the (first) administration of IMP.
• Severe ischaemia in the target leg at screening or time of the (first) administration of IMP defined as an ankle brachial index (ABI) \< 0.5.
• Necrotic tissue in leg wound at time of the (first) administration of IMP.
• Clinically significantly reduced perception of sensation or pain assessed in proximity of the wound at screening.
• A pain score from the leg wound above 4 assessed on a 10 cm VAS , where 0 cm indicates no pain at all and 10 cm indicates the worst imaginable pain at time of the (first) administration of IMP.
• Use of opioids from time of screening to end of study, unless used a at stable dose, as judged by the Investigator.
• Participation in the treatment phase of a clinical study with an investigational new drug within 30 days or 5 half-lives (whichever is longer) before the (first) administration of IMP.
• Has previously received SBE in any of the concentrations tested in the current study.
• Pregnant or lactating at screening or time of the (first) administration of IMP.
• Ascertained or presumptive allergy/ hypersensitivity to any components of the IMP; history of anaphylaxis to drugs or serious allergic reactions leading to hospitalisation or any other allergy reaction in general, which the Investigator considers may affect the safety of the patient and/or outcome of the study.
• Inability to communicate or cooperate with the Investigator (e.g., language problems, illiteracy, poor mental status) or to comply with the requirements of the study.
• Other factors which in the opinion of the Investigator may interfere with study conduct.

Sponsors & Collaborators

• SoftOx Solutions AS: lead

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Peick Sonne, MD; PhD

  Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

• Glenn Gundersen, PhD

  SoftOx Solutions A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding and unblinding procedures applied only to the single-dose groups, i.e., Groups 1-4, randomized to receive SBE (active) or sterile saline (placebo). The computer-generated randomisation list was kept strictly confidential, accessible only to authorised persons, until the time of unblinding of the study. The following procedures were implemented in the single-dose groups to minimise the risk of unintended unblinding: i. Blinded staff prepared the patient's leg wound for the administration of IMP. ii. Both patient and blinded staff applied a nose clip, prior to and during IMP administration, until all materials used for the treatment (plastic wrapping, gauze, gallipot, etc.) had been removed and the room had been vented for a couple of minutes by opening a window.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blinded, placebo-controlled ascending single dose groups (Groups 1 to 4); followed by open-label multiple ascending dose groups (Groups 5 to 7)

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: February 2, 2023
• Study Start: October 19, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)