A First-in-Human Randomized Clinical Study Investigating the Safety and Tolerability of Stabilized Hypochlorous Acid in Patients with Chronic Leg Ulcers.

Objective: 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.

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.

BACKGROUND: Alcohol-based hand rub (ABHR) is widely used for hand disinfection in the health care sector. ABHR is, however, known to cause discomfort when applied on damaged skin emphasizing the unmet need for alternative and better tolerated types of disinfectants. Active chlorine hand disinfectants (ACHDs) are potential new candidates; however, the effect on the skin barrier function compared to ABHR remains to be assessed. MATERIALS AND METHODS: In Study A, the forearm skin of healthy adults was repeatedly exposed to ACHD and ABHR. Skin barrier function was assessed by measurement of transepidermal water loss, electrical conductance, pH, and erythema at baseline and at follow-up after 2 days, and subjective discomfort was likewise assessed. Study B was performed in the same way; however, in order to induce an experimental irritant contact dermatitis, sodium lauryl sulfate patch tests were applied to forearms before exposure to ACHD and ABHR. 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. CONCLUSION: Our results illustrate that use of ACHD does not affect the skin barrier function negatively, neither in intact skin nor in skin with experimentally induced contact dermatitis. Future studies should include real-life evaluation of skin barrier function and subjective discomfort following ACHD use in individuals with and without hand eczema.