Australasian Journal of Dermatology (2019) , – doi: 10.1111/ajd.

13153

ORIGINAL RESEARCH

Skin benefits of moisturising body wash formulas for

children with atopic dermatitis: A randomised controlled
clinical study in China
Zigang Xu1 | Xiaoyan Liu2 | Yueqing Niu3 | Chunping Shen1 | Kate Heminger4 | Laurie
Moulton | Amy Yu3 | Tina Allen4 | Lesheng Zhang3 | Feng Yue3 | Jiquan Liu5 | Ying
4

Xu5 | Helen Zhao5 | Lijuan Li4 | Tom Cambron4 | Jian Xu6 | Ed Smith4 | Karl Wei4
1
Department of Dermatology, Beijing Children’s Hospital, Capital Medical University, 2Department of
Dermatology, Capital Institute of Pediatrics, 3Procter & Gamble Beijing Innovation Center, Beijing, China,
4
Procter & Gamble Mason Business Center, Mason, Ohio, USA, 5Procter & Gamble Singapore Innovation Center,
Singapore City, Singapore, and 6Qingdao Institute of BioEnergy and BioProcess Technology, Chinese Academy
of Sciences, Qingdao, China

ABSTRACT Methods: A randomised controlled clinical study

Background: It acknowledged that skin care is an
important part of atopic dermatitis therapy. How-
ever, clinical evidences are limited for the best bath-
ing practices, especially the skin health performance
of cleansing products on children’s atopic dermatitis
skin.
Correspondence: Karl Wei, Procter & Gamble Mason Business
Center, Mason, OH 45040, USA. Email: wei.ks@pg.com
Zigang Xu, MD. Xiaoyan Liu, MD. Yueqing Niu, MD.
Chunping Shen, MD. Kate Heminger, PhD. Laurie Moulton, MS.
Amy Yu, BS. Tina Allen, BS. Lesheng Zhang, PhD. Feng Yue,
MS. Jiquan Liu, PhD. Ying Xu, PhD. Helen Zhao, PhD. Lijuan
Li, PhD. Tom Cambron, PhD. Jian Xu, PhD. Ed Smith, BS. Karl
Wei, PhD.
Consent for Publication from All Authors: Yes.
Funding information: This study was supported by a research
grant from The Procter &Gamble Company.
Conflict of interest: Yueqing Niu, Kate Heminger, Laurie
Moulton, Amy Yu, Tina Allen, Lesheng Zhang, Feng Yue, Jiquan
Liu, Helen Zhao, Lijuan Li, Tom Cambron, Ed Smith and Karl Wei
contributed to and/or conducted this study while employed by The
Procter & Gamble Company. The other authors declare that they
have no conflict of interest.
Study ethics: This study protocol complied with the ethical
guidelines of the 1975 Declaration of Helsinki and was approved
by the institutional review committee of Beijing Children’s
Hospital and conducted per ICH guidelines for Good Clinical
Practice. Written informed consent was obtained from the parent/
legal guardian of each subject and verbal assent from each
subject. No recognisable photographs were collected from this
study.
Submitted 28 January 2019; accepted 5 August 2019.
was conducted in China among 4- to 18-year-old
children with mild-to-moderate atopic dermatitis to
evaluate the skin health effect of three cleansing
systems (a mild synthetic bar, an ultra-mild body
wash with lipids, and an ultra-mild body wash with
lipids and zinc pyrithione) by measuring SCORing
of Atopic Dermatitis (SCORAD), consumption of
topical corticosteroid and the characteristics of
microbiome.
Results: Increased Staphylococcus aureus abun-
dance and decreased microbial diversity were
observed in atopic dermatitis lesion sites compared
with healthy control sites. After 4 weeks of treat-
ment, all three treatments showed clinically impor-
tant improvement from baseline in SCORAD. Four-
week corticosteroid consumption was significantly
lower for the two body wash groups than the bar
group. A significant decrease in S. aureus abundance
and increase in microbial diversity were observed in
the lesion sites for the two body wash formulas,
while the microbial diversity was statistically insig-
nificant for the mild cleansing bar group. However,
there were no incremental benefits provided by the
body wash formulas based on the assessment of
SCORAD.
Conclusions: These results demonstrated the safety
and efficacy of using the investigational body wash
formulas with lipids in reducing the needs for corti-
costeroid and improving the healthy composition of
skin microbiome vs. the mild synthetic bar soap.
Key words: atopic dermatitis, body wash, micro-
biomes, skin health.

© 2019 The Australasian College of Dermatologists

2 Z Xu et al.
INTRODUCTION
Maintaining and enhancing epidermal barrier function
plays a critical role in atopic dermatitis (AD) treatment.
Use of moisturisers is considered as an effective way to
prevent transepidermal water loss (TEWL), prevent flare-
ups and reduce the need for pharmacologic treatment.
Bathing for AD patients can be double-edged: it removes
crusts, irritants, allergens and bacterial plaques, but at the
same time poses further challenges to epidermal barrier
integrity.1
The development of moisturising body wash products is
one of the more significant changes to affect the personal
cleansing market in recent years.2 A key factor contribut-
ing to the popularity of these products is that the advanced
body wash technologies can be designed to deliver better
skin care benefits than regular cleansing body washes or
mild bat soaps.
The aim of study was to evaluate the health effect of
three cleansing systems, a mild synthetic bar, an Ultra-
Mild Body Wash with Lipids, and an ultra-mild body wash
with lipids and zinc pyrithione (ZPT) among children with
mild-to-moderate AD conditions.
MATERIALS AND METHODS
Study design
This was a randomised, single-blind, parallel group, in
home use study consisting of 1-week pre-conditioning
phase, 4-week treatment phase and 2-week follow-up
phase, conducted over the period May to July 2015. This
study protocol was approved by the institutional review
committee of Beijing Children’s Hospital and conducted
according to ICH guidelines for Good Clinical Practice.
Written informed consent was obtained from the parent/le-
gal guardian of each subject and verbal assent from each
subject prior to screening. There is no conflict of interest
with the products used.
Subject
Subjects were recruited from the Outpatient Department of
Pediatric Dermatology, Beijing Children’s Hospital and
Capital Institute of Pediatrics.
The AD group were 4–18 years of age (inclusive), diag-
nosed as mild-to-moderate AD according to the Physician’s
Global Assessment (PGA = 2 or 3) with active lesions invol-
ving 5% to 30% of the body surface. Healthy controls were
age- and gender-matched to the AD group, with no history
or current presentation of AD.
Intervention
After baseline visit, the healthy control subjects were dis-
charged from the study, and the AD subjects were ran-
domised into three treatment groups (a mild synthetic bar,
an ultra-mild body wash with lipids, and an ultra-mild
body wash with lipids and ZPT) and required to wash once
daily with the assigned investigational product. The key
© 2019 The Australasian College of Dermatologists
ingredients of the mild synthetic bar are sodium lauryl
isethionate, paraffin, sodium cocoglyceryl ether sulpho-
nate, glycerine, water etc. The key ingredients of the ultra-
mild body wash with lipids are water, petrolatum, sodium
trideceth sulphate, sodium chloride, cocamidropropyl
betaine, trideceth-3, fragrance, guar hydroxypropyltrimo-
nium chloride, sodium benzoate, xanthan gum, glyceryl
oleate etc. The key ingredients of the ultra-mild body wash
with lipids and ZPT are water, petrolatum, sodium tride-
ceth sulphate, sodium chloride, cocamidropropyl betaine,
trideceth-3, fragrance, guar hydroxypropyltrimonium chlo-
ride, sodium benzoate, xanthan gum, glyceryl oleate, zinc
pyrithione etc. Additionally, all subjects were asked to
apply 0.1% hydrocortisone butyrate cream to their AD
lesion sites once per day until the lesion was gone using
the ‘the fingertip unit method’, in place of their previous
topical medication. Upon completion of the 4-week treat-
ment phase, subjects discontinued the use of topical corti-
costeroid for the following 2-week follow-up phase. No
other products or medications were allowed except those
provided by this study.
Measurement and sample collection
During each visit, subjects acclimated in a controlled tem-
perature and controlled humidity room for at least 30 min
prior to sample collection. A trained dermatologist, blinded
to the three treatment groups, used the SCORing of Atopic
Dermatitis (SCORAD) to evaluate the severity of AD. The
amount of investigational products and topical corticos-
teroid used was also collected.
Swab samples were collected by applying each swab onto
a 10 cm2 skin site in both horizontal and vertical directions
for total 50 times. The sampling procedures were per-
formed by trained technicians, and were stored in 80°C
freezer until analysed for biomarker and microbiome.3
Statistical analysis
A mixed model was used with subject (random effect) and
skin type (fixed effect) for comparison of lesion, non-lesion
and the skin of healthy controls at baseline.
For comparison of 4-week usage of corticosteroid, a
fixed effects model was used to compare treatments with
baseline severity (PGA: mild/moderate) as a covariate.
Change from baseline in measurement variables was
analysed separately using a mixed model for repeated mea-
sures with subject nested within treatment (random effect),
and treatment, week, treatment-by-week, age and baseline
(fixed effects). The type I error rate was 5% (i.e. signifi-
cance level) based on a two-sided test. Marginal signifi-
cance was concluded at 10%. Outliers were excluded based
on being greater than 4 standard deviations from the mean.
RESULTS
Demographics
Sixty-seven patients with AD, and 28 healthy controls were
enrolled. The two groups were matched in age and
 Skin benefits of moisturising wash for AD children
gender. AD subjects were further randomised into three
treatment groups and balanced in baseline SCORAD, age
and gender.
Baseline microbiome of AD lesion, AD non-lesion
and healthy control sites
Relative abundance of Staphylococcus, both at the genus
level and at the species level (represented by S. aureus
and S. epidermidis), was the highest at lesion sites, fol-
lowed by non-lesion sites, and the lowest at healthy control
sites (Fig. 1, all P < 0.05). Other common skin commensals
including Corynebacterium, Micrococcus, Cutibacterium
(formerly Propionibacterium) and Streptococcus showed
higher relative abundance at healthy control sites and
non-lesion sites than lesion sites (Fig. 1, all P < 0.05).
Alpha diversity was the lowest at lesion sites, followed
by non-lesion sites, and the highest at healthy control sites
(Fig. 2, all P < 0.05).
Treatment comparisons between body washes
and synthetic bar
Tolerance
All subjects tolerated the investigational products very
well, with no reports of adverse skin reactions related to
the use of the products. Five of the 67 subjects reported
Figure 1 Relative abundance at genus and species level for healthy, lesion and non-lesion sites.
3
lesion relapse; these were randomly distributed to all treat-
ment groups.
SCORAD
SCORAD was decreased for all treatments after 4 weeks of
treatment and slightly elevated after 2 weeks of follow up.
The magnitude of reduction achieved clinically important
difference (8.7 units) compared to baseline for all treat-
ment groups (all P < 0.05); however, it was not signifi-
cantly different across treatment groups (Fig. 3).
Corticosteroid consumption
Four-week corticosteroid consumption was significantly
lower for the two body wash groups (6.7  1.1 g in the
lipids group and 5.6  1.1 g in the lipids with zinc pyr-
ithione group, respectively) than the bar group
(10.1  1.2 g, both P < 0.05). There was no significant dif-
ference between the two body wash groups.
Microbiome
For the lipid with zinc pyrithione group, the composition
of microbiome community was shifted and achieved
greater similarity to the healthy control sites; furthermore,
the relative abundance of Staphylococcus at genus level
© 2019 The Australasian College of Dermatologists
4 Z Xu et al.
Figure 2 Relative abundance and alpha diversity for healthy, lesion and non-lesion sites.
Figure 3 Treatment effect in SCORAD.
and S. aureus at species level was significantly reduced
based on 16S rDNA sequencing data (P < 0.05), which was
further confirmed by qPCR test (data not shown), while the
relative abundance of Corynebacterium, Micrococcus, Cuti-
bacterium and Streptococcus was significantly increased
(all P < 0.05), comparing to the mild synthetic bar soap
group.
Alpha diversity was significantly increased at the lesion
sites for the two body wash groups vs. baseline (Fig. 4,
both P < 0.05), while the alpha diversity was statistically
flat for the mild synthetic bar soap treatment group vs.
baseline (Fig. 4, P = 0.23).
DISCUSSIONS
Up to 90% of adults with AD have been found to be colo-
nised with large numbers of S. aureus on their skin, which
can be cultured not only from eczematous plaques but also
from clinically normal skin. In contrast, only 5% of the
normal population carry S. aureus which is largely found
in the nares and intertriginous areas.4 In AD patients, both
lesion and non-lesion skin carry super antigenic-producing
© 2019 The Australasian College of Dermatologists
S. aureus, which are capable of modifying T-cell
responses, resulting in increased inflammation. It has been
shown that a reduction in S. aureus levels on the skin is
accompanied by an improvement in AD.5 In addition,
microbial diversity at AD lesion sites is significantly lower
than non-lesion sites and skin sites from healthy subjects
among Caucasians.6–8 Our study revealed similar findings
among Chinese children. The comparisons between AD
non-lesion sites and healthy control sites suggest that AD
skin, even before progression to a symptomatic stage, has
increased S. aureus abundance and decreased microbial
diversity.
Dermatologic therapy for mild-to-moderate AD typi-
cally focuses on treatment with topical corticosteroids or
calcineurin inhibitors to alleviate AD symptoms, reduce
inflammation and prevent flares. An important factor in
reducing inflammation is selection of skin cleanser sys-
tem. Body washes containing topical antiseptics are used
as alternative treatments to antibiotics for patients with
AD. Those antiseptics include sodium hypochlorite, tri-
closan, benzalkonium chloride and potassium perman-
ganate.9,10 In this study, we compared two body wash
formulas vs. a synthetic bar among mild-to-moderate AD
children using 0.1% hydrocortisone butyrate cream as
the standard therapy. As the treatment effect was domi-
nated by the corticosteroid, we did not observe an incre-
mental benefit provided by the body wash formulas
based on the assessment of SCORAD. However, there
was a significant reduction in corticosteroid consumption
in the body wash groups. We hypothesise that the corti-
costeroid reduction benefit was enabled by the moisturis-
ing wash technology, which deposits lipids onto skin
during the shower and functions synergistically with
topical corticosteroid.
We observed that the elevated Staphylococcus at the AD
lesion sites was reduced and the suppressed normal com-
ponents of skin microflora were improved, leading to an
improved microbial diversity and more balanced micro-
biota composition in the two moisturising body wash
groups (Fig. 4). This is consistent with the report that
 Skin benefits of moisturising wash for AD children
Figure 4 Treatment effect in relative abundance and alpha diversity.
emollient use increased the microbial diversity in infants
at risk for developing atopic dermatitis.11
It appears that zinc pyrithione has an incremental bene-
fit for reducing Staphylococcus and increasing microbial
index beyond the lipid only treatment effect (Fig. 4). Zinc
pyrithione is an active material that has used for over
50 years to effectively treat dandruff and seborrhoeic der-
matitis.12–14 Zinc pyrithione is proven to be effective, even
at low concentrations, against both gram-positive and
gram-negative bacteria and fungi.12 In vitro testing indi-
cates that the inhibitory concentration of zinc pyrithione is
achieved at a level of 10 lg/mL (10 ppm) for S. aureus.12
Zinc pyrithione particles can be deposited and retained on
the skin surfaces during the cleansing process. The depos-
ited zinc pyrithione particles can interact with the surface
fungal and bacteria cells to control their population and
provide persistent benefit.13 Results from the present study
indicate that the over colonisation of Staphylococcus on AD
skin is averted by treating the skin with a mild yet effica-
cious antimicrobial body wash. More importantly, it allows
the healthy components of natural microbial community to
grow back and prevents the Staphylococcus triggered AD
pathogenesis.
In summary, the present results demonstrated the safety
and efficacy of using the investigational body wash formu-
las in reducing the needs for corticosteroid and improving
the healthy composition of skin microbiome vs. the mild
synthetic bar soap.
5
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