An Investigator Blinded Randomized Study Evaluating HOCl in the Treatment of 
Atopic Dermatitis-Associated Pruritus

Brian Berman, MD, PhD; Mark Nestor, MD, PhD
Center for Clinical and Cosmetic Research and University of Miami Miller School of Medicine

Introduction
Atopic dermatitis (AD) is a chronic inflammatory skin disease
characterized by pruritus. It affects up to 20% of children and
3% of adults worldwide, and its prevalence is increasing.1 The
impact of pruritus in AD can range from mildly distressing to
completely disabling.2

Hypochlorous acid (HOCl) has been identified as a treatment
for pruritus.3 There are 2 mechanisms by which HOCl may
reduce pruritus: 1) by its microbicidal qualities, particularly in
the case of Staphylococcus aureus; and 2) by its anti-
inflammatory qualities, which help reduce the activity of
histamine, leukotriene B4, and interleukin-2, all of which
contribute to the pathophysiology of itch.4-7

Here we present the results of a 3-day study designed to
evaluate the effect of HOCl on pruritus in patients with AD.

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
2 72-hour study investigated the antipruritic effect of HOCl in
patients diagnosed with AD. Subjects were enrolled into the study if
they had AD as defined by the Hanifin criteria and had a score of >2
on an itch severity scare (0-4). 30 subjects were enrolled over the
course of the study, with 20 randomized to the treatment group
(HOCl), and 10 randomized to the untreated control group. Subjects
who were randomized to the treatment group were instructed to use
HOCl BID or PRN for 72-hours while recording the date and time of
applications in a study 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 3 primary measures used in this study were the Participant Global
Assessment (PGA), Investigator Global Assessment (IGA), and VAS itch
score (indicated by a 154 mm line). PGA was defined as the mean of
five 5-point ordinal scales (0-none, 4-severe) for subject rated overall
irritation, peeling, stinging, burning, and itching. The IGA was defined
as the mean of eight 5-point ordinal scales (0-4, none-severe) for
erythema, desquamation, lichenification, overall irritation, excoriation,
and subject queried stinging, burning and itching. The VAS itch score
was defined as the number of millimeters from the left side of a line
(154 mm in length) that indicates their level of itching (0 mm no
itching to 154 mm most itching). Along with the 3 primary measures,
incidence of unexpected 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.

Photographic evidence was used to confirm evaluations.

Material and Methods

Table 1. Baseline Investigator Elicited Itch Score (0-4)

Results

Thirty subjects were enrolled into the study in a 2:1 ratio
(treated:untreated), and 29 were included in the final analysis.
The mean VAS itch score between the 2 groups were similar at
baseline (Table 1). Mean change in PGA and IGA between
baseline and 72-hours were both shown to be significantly
different, with a decrease (improvement) in favor of the
treatment group (PGA: p-value=0.128; IGA: p-value=0.012)
(Figure 1). 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 in the treated group (Figure 2).

At the conclusion of the study, subjects in both groups were
separated into those who had less itch (difference in itch
between baseline and 72 hours was positive), same itch
(difference in itch between baseline and 72 hours was equal to
zero), or more itch at 72 hours (difference in itch between
baseline and 72 hours was negative) (Figure 3). The analysis
showed 73.7% of the subjects in the treated and 30.0% of the
subjects in the untreated group experienced a reduction in
itching between baseline and 72 hours post application. There
were no treatment related discontinuations or SAEs. One
subject reported mild to moderate transient facial dryness
which spontaneously resolved when that subject applied the
gel to the face. Figure 4 shows photographic evidence of a
significant decrease in AD characteristics (erythema, dryness,
desquamation) at 72 hours.

Figure 1. Mean Change in PGAD3-D1 and IGAD3-D1 With and 
Without Treatment with HOCl Gel x 3 day

-0.25

-0.2

-0.15

-0.1

-0.05

0

0.05

0.1

-0.158

-0.237

0.08

-0.013
HOCl Treated x 3d

Untreated x 3d

'PGA 'IGA

p<0.128

Figure 2. Mean % Change in Itch VAS With and Without 
Treatment with HOCl Gel x 3 days

Conclusions

This study demonstrated that HOCl leads to a significant
reduction in itching associated with AD in as little as 72 hours.
Additionally, the twice daily regimen was manageable and easy
to follow, as demonstrated by a high rate of compliance.

HOCl is effective over a short period of time with few doses
needed. This is a cost efficient and effective method for
improving the symptom of pruritus in patients with AD.

Figure 3. Effect of Treatment with HOCl Gel x3 days on 
Itch in Atopic Dermatitis

Figure 4. Subject treated with HOCl before (left) and 72 
hours after (right) treatment 

References

1.  Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann 
Nutr Metab. 2015;66(suppl 1):8-16.
2.  Elmariah SB. Adjunctive management of itch in atopic dermatitis. Derm
Clin. 2017;35(3):373-394.
3.  Pelgrift RY, Friedman AJ. Topical hypochlorous acid (HOCl) as a 
potential treatment of pruritus.  Curr Derm Rep. 2013; 2:181–190.
4.  Garibyan L, Rheingold CG, Lerner EA. Understanding the 
pathophysiology of itch. Dermatol Ther. 2013;26(2):84–91.
5.  Greaves MW. Pathogenesis and treatment of pruritus. Curr Allergy 
Asthma Rep. 2010;10(4):236–42. 
6.  Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Curr
Allergy Asthma Rep. 2008;8(4):306–11.
7.  Friedman AJ, Cash K, Berman B. Hypochlorous Acid is 
Antiinf lammatory and Immunomodulatory. Poster. Presented at the 
Winter Clinical Dermatology Conference, Kauai, HI, January 18, 2013.

Supported in part by Onset and IntraDerm.

Baseline At 72-hours

Day 2 Day 3

Change in VAS score 
0-72 hours/Baseline  
VAS Score x 100%

-59.50% -84.50%


	FC17PosterIntraDermBermanAnInvestigatorBlindedStudy.pdf