An investigator blinded randomized study evaluating hypochlorous acid (HOCl) in the treatment of atopic dermatitis-associated pruritus
Presenters: Berman B, Nestor M
Affiliation: Center for Clinical and Cosmetic Research and University of Miami Miller School of Medicine, Miami, FL
Background/Objective: Hypochlorous acid (HOCl) might potentially reduce pruritus in atopic dermatitis (AD) by its microbicidal qualities, particularly in reducing Staphylococcus aureus, and by its anti-inflammatory qualities that reduce the activities of histamine, leukotriene B4, and interleukin-2, all of which contribute to the pathophysiology of itch. Here, we present the results of a three-day study designed to evaluate the effect of HOCl on pruritus in patients with AD.
Methods: The study was conducted according to the protocol and in compliance with Good Clinical Practice (GCP) and other applicable regulatory requirements. This investigator-blinded, randomized Phase II, 72-hour study investigated the antipruritic effect of HOCl with patients diagnosed with AD. Subjects enrolled had AD as defined by the Hanifin criteria and had scored higher than 2 on an itch severity scale (0–4). Thirty subjects were enrolled, 20 randomized to the treatment group (HOCl), and 10 randomized to the untreated control group. Subjects used a HOCl containing solution BID or PRN for 72 hours and recorded applications in a diary. Subjects randomized to the untreated group received no treatment and were only instructed to come to follow-up visits for study-specific assessments.
The three primary measures used were Participant Global Assessment (PGA), Investigator Global Assessment (IGA), and Visual Analog Scale (VAS) itch score. Adverse events (AEs) and serious adverse events (SAEs) and incidence of local skin reactions leading to discontinuation were recorded as well. Measurements were taken at baseline, 24 hours, and 72 hours post-treatment. Photographs of representative areas of affected skin were taken.
Results: The mean VAS itch score between the two groups was similar at baseline. Mean change in PGA and IGA scores between baseline and 72 hours both significantly decreased in favor of the HOCl treatment group (PGA: p value=0.128; IGA: p=0.012). The mean itch VAS scores between the treated and untreated groups were significantly different between baseline and 72 hours post-application, with the percent mean change shown to be significantly lower (improved) in the HOCl treated group.
The analysis showed 73.7 percent of the subjects in the HOCl treated and 30.0 percent of the subjects in the untreated group experienced a reduction in itching between baseline and 72 hours after initial application. There were no treatment related discontinuations or SAEs.
Conclusion: This study demonstrated that application of HOCl-containing solution leads to a reduction in itching associated with AD at 24 hours with significantly better results when compared to the untreated cohort at 72 hours.