Short-term safety and local tolerability of repeated exposure to aerosolized hypochlorous acid dry fog in healthy adults: a randomized controlled pilot study
5 affiliations
- 1Jagiellonian University Medical College
- 2MTZ Clinical Research MTZ Powered by Pratia
- 3Biodefense Laboratory, Biomedical Engineering Centre, Institute of Optoelectronics, Military University of Technology
- 4BioMedAqua Sp. z o.o.
- 5Biomedical Engineering Center, Institute of Optoelectronics, Military University of Technology
Abstract
Background: Hypochlorous acid (HOCI) is an oxidizing chlorine-based compound with broad antimicrobial activity and potential application as a dry-fog disinfectant in healthcare environments. However, human safety data for repeated exposure to aerosolized HOCI remain limited. This study evaluated the short-term safety and local tolerability of aerosolized HOCI dry fog under controlled conditions.
Methods: This prospective, randomized, open-label pilot study included healthy adult volunteers aged 18–65 years. Participants were enrolled into two independent exposure cohorts and randomized 1:1 to aerosolized HOCI or aerosolized 0.9% sodium chloride. The investigational product was a 300-ppm HOCI solution dispersed as dry fog at 20 mL/m ³ . In the short repeated exposure cohort, participants underwent three 3-min exposures per day for 3 consecutive days. In the prolonged repeated exposure cohort, participants underwent one 60-min exposure per day for 9 consecutive days. Safety assessments included adverse events, vital signs, hematology, routine biochemistry, serum cytokines, laryngological examination with rhinoscopy, nasal cytology, and conjunctival assessment.
Results: Eighty participants were randomized, 40 in each exposure cohort. No serious adverse events occurred, and no participant discontinued the study because of an adverse event. In the short repeated exposure cohort, adverse events were reported in 9/20 participants receiving HOCI and 3/20 receiving sodium chloride (45% vs. 15%; p = 0.082). In the prolonged repeated exposure cohort, adverse events were reported in 13/20 participants receiving HOCI and 0/20 receiving sodium chloride (65% vs. 0%; p < 0.001). All adverse events in the prolonged exposure cohort were mild; two were classified as definitely related to HOCI exposure. No persistent laryngological or conjunctival abnormalities were observed. Cytokine concentrations showed no consistent exposure-related pattern or sustained systemic inflammatory activation. Vital signs and routine laboratory parameters showed no clinically relevant systemic toxicity signal.
Conclusion: Under the controlled exposure conditions tested, aerosolized HOCI dry fog was generally well tolerated in healthy adults. Prolonged repeated exposure was associated with more frequent non-serious, mild adverse events, but without serious adverse events, persistent local irritation, systemic inflammatory activation, or clinically meaningful laboratory toxicity.
Related
- Aerosolized prostaglandin E₁ improves oxygenation during one-lung ventilation: A dose-finding randomized controlled trial.
- A Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of intravenous ertapenem and zidebactam in combination (WCK 6777) in healthy adult subjects
- Repeated prefrontal transcranial direct current stimulation improves behavioral regulation and modulates resting-state EEG microstate dynamics in young adults with problematic smartphone use: a randomized sham-controlled longitudinal study
- Twelve-Month Efficacy and Visual Tolerability of MyoPi Spectacle Lenses in Childhood Myopia : A Randomized Clinical Trial
- Safety, Tolerability and Antiviral Activity of GST‐HG131 in Chronic Hepatitis B: A Randomized, Double‐Blind Phase IIa Study
BibTeX
@article{sanak2026shortterm,
title = {{Short-term safety and local tolerability of repeated exposure to aerosolized hypochlorous acid dry fog in healthy adults: a randomized controlled pilot study}},
author = {Tomasz Sanak and Marta Zakrzewska and Jacek Bil and Łukasz Krzowski and Grzegorz Witkowski and Zygmunt Mierczyk},
journal = {Frontiers in Public Health},
year = {2026},
month = oct,
doi = {10.3389/fpubh.2026.1970564},
url = {https://www.frontiersin.org/articles/10.3389/fpubh.2026.1970564/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Short-term safety and local tolerability of repeated exposure to aerosolized hypochlorous acid dry fog in healthy adults: a randomized controlled pilot study
AU - Tomasz Sanak
AU - Marta Zakrzewska
AU - Jacek Bil
AU - Łukasz Krzowski
AU - Grzegorz Witkowski
AU - Zygmunt Mierczyk
PY - 2026
DA - 2026/10/26
JO - Frontiers in Public Health
DO - 10.3389/fpubh.2026.1970564
UR - https://www.frontiersin.org/articles/10.3389/fpubh.2026.1970564/full
AB - Background: Hypochlorous acid (HOCI) is an oxidizing chlorine-based compound with broad antimicrobial activity and potential application as a dry-fog disinfectant in healthcare environments. However, human safety data for repeated exposure to aerosolized HOCI remain limited. This study evaluated the short-term safety and local tolerability of aerosolized HOCI dry fog under controlled conditions. Methods: This prospective, randomized, open-label pilot study included healthy adult volunteers aged 18–65 years. Participants were enrolled into two independent exposure cohorts and randomized 1:1 to aerosolized HOCI or aerosolized 0.9% sodium chloride. The investigational product was a 300-ppm HOCI solution dispersed as dry fog at 20 mL/m ³ . In the short repeated exposure cohort, participants underwent three 3-min exposures per day for 3 consecutive days. In the prolonged repeated exposure cohort, participants underwent one 60-min exposure per day for 9 consecutive days. Safety assessments included adverse events, vital signs, hematology, routine biochemistry, serum cytokines, laryngological examination with rhinoscopy, nasal cytology, and conjunctival assessment. Results: Eighty participants were randomized, 40 in each exposure cohort. No serious adverse events occurred, and no participant discontinued the study because of an adverse event. In the short repeated exposure cohort, adverse events were reported in 9/20 participants receiving HOCI and 3/20 receiving sodium chloride (45% vs. 15%; p = 0.082). In the prolonged repeated exposure cohort, adverse events were reported in 13/20 participants receiving HOCI and 0/20 receiving sodium chloride (65% vs. 0%; p < 0.001). All adverse events in the prolonged exposure cohort were mild; two were classified as definitely related to HOCI exposure. No persistent laryngological or conjunctival abnormalities were observed. Cytokine concentrations showed no consistent exposure-related pattern or sustained systemic inflammatory activation. Vital signs and routine laboratory parameters showed no clinically relevant systemic toxicity signal. Conclusion: Under the controlled exposure conditions tested, aerosolized HOCI dry fog was generally well tolerated in healthy adults. Prolonged repeated exposure was associated with more frequent non-serious, mild adverse events, but without serious adverse events, persistent local irritation, systemic inflammatory activation, or clinically meaningful laboratory toxicity.
SN - 2296-2565
ER -