Scientific Publications

Fazli et al (2024): A First-in-Human Randomized Clinical Study Investigating the Safety and Tolerability of Stabilized Hypochlorous Acid in Patients with Chronic Leg Ulcers

Purpose:

Biofilm infections in chronic wounds are common and pose a significant clinical challenge. This challenge was addressed by developing the SoftOx Biofilm Eradicator (SBE) composed of hypochlorous acid (HOCl) and acetic acid with strong broad-spectrum antimicrobial activity.

Approach:

First-in-human study investigating the safety and tolerability as primary endpoints and wound size effect and antimicrobial efficacy as secondary endpoints of SBE treatment in chronic leg wound patients. The study was divided into two as follows: a randomized, double-blinded, Single Ascending Dose (SAD) phase (n = 16 SBE; n = 4 placebo), where patients were treated with SBE or saline (placebo) only once, followed by an open-label, Multiple Ascending Dose (MAD) phase (n = 8), where patients were treated with SBE once daily or twice daily over five days. Reporting is according to CONSORT guidelines.

Results:

SBE was safe and well-tolerated in chronic leg wound patients. There were no significant differences in pain during and after treatment with SBE or the placebo. The SBE treatment reduced bioburden in wounds compared to baseline, with 98% and 49% median reduction after SBE or placebo treatment, respectively. A dose-dependent trend in absolute wound size reduction was observed in the MAD groups with a median (min, max) change of −2.99 (−14.25, −1.5) cm² in the once-daily and −10.48 (−17.95, −0.38) cm² in the twice-daily group, respectively.

Innovation and Conclusion:

This study demonstrated the safe use of HOCl-based SBE in chronic leg wounds with promising trends of immediate antimicrobial action and beneficial effect on wound healing.

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Adherne et al (2022): Effects of stabilized hypochlorous acid on oral biofilm bacteria

Purpose:

Caries and periodontitis are amongst the most prevalent diseases worldwide, leading to pain and loss of oral function for those affected. Prevention relies heavily on mechanical removal of dental plaque biofilms but for populations where this is not achievable, alternative plaque control methods are required. With concerns over undesirable side-effects and potential bacterial resistance due to the use of chlorhexidine gluconate (CHX), new antimicrobial substances for oral use are greatly needed. Here we have investigated the antimicrobial effect of hypochlorous acid (HOCl), stabilized with acetic acid (HAc), on oral biofilms and compared it to that of CHX.

Results:

Low concentrations of HOCl (5 ppm), stabilized with 0.14% or 2% HAc, significantly reduced viability in multi-species biofilms representing supra- and sub-gingival oral communities, after 5 min, without causing erosion of HA surfaces. No equivalent antimicrobial effect was seen for CHX. Gram-positive and Gram-negative bacteria showed no significant differential suceptibility to stabilized HOCl.

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Burain et al (2022): Effect of stabilized hypochlorous acid on re-epithelialization and bacterial bioburden in acute wounds: A randomized controlled trial in healthy volunteers

Purpose:

The aim of this randomized controlled trial was to evaluate the wound-healing effect and antimicrobial properties of a novel stabilized hypochlorous acid solution on acute wounds, using a suction blister wound model.

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Burain et al (2021): The safety and antimicrobial properties of stabilized hypochlorous acid in acetic acid buffer for the treatment of acute wounds—a human pilot study and in vitro data

Purpose:

A first-in-man, prospective, open-label, exploratory pilot study to document the preliminary safety and performance of HOCl+buffer for topical use when used on acute wounds.

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Yüksel et al (2021): Skin barrier response to active chlorine hand disinfectant—An experimental study comparing skin barrier response to active chlorine hand disinfectant and alcohol-based hand rub on healthy skin and eczematous skin

Purpose:

The aim of the present study was to examine the skin barrier response to ACHD compared with ABHR on intact skin and on skin with experimentally induced irritant contact dermatitis in healthy individuals, respectively.

Results:

In both studies, the skin barrier function was unaffected after repetitive exposure to ACHD and ABHR, and with no significant differences between the products. Subjective discomfort was reported as sporadic or very mild in relation to both products.

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