Efficacy and Tolerability of an Oatmeal Moisturizer Containing Colloidal Oatmeal for Dry Skin Conditions: A Post-marketing Study

Abstract

Background: Skin dryness is a common condition that represents significant change in the outermost layer of the epidermis of the skin. Oatmeal moisturizer therapy plays an important role in treating various skin diseases. Methodology/Principal findings: The study included a total of 528 patients aged 2-65 years with atopic dermatitis/xerosis, eczema, acne, psoriasis and other types of skin infections. The patients were treated with oatmeal moisturizer (Nourish Oat) for a duration of 8 weeks. All the patients were evaluated with modified Kligman grading scale, before and after the end of therapy. There was a significant improvement (p < 0.05) with an increase in the mean difference in dryness scores from baseline to the end of each treatment interval (2 weeks-0.88, 4 weeks-1.43, 6 weeks-1.77 and 8 weeks-1.93). The mean differences in itching scores from baseline to the end of treatment were 0.09 after 2 weeks (p < 0.05), 1.66 after 4 weeks (p < 0.05), 0.09 after 6 weeks (p < 0.22) and 1.66 after 8 weeks (p < 0.05). Overall, 53% and 59% patients had reduced dryness >60% and reduced itching, respectively after 4 weeks of treatment period and 89% and 93% patients had reduced dryness >80% and reduced itching, respectively at the end of 8 weeks. No serious skin reactions were reported. Conclusion: Nourish Oat shows good tolerability, efficacy and demonstrates significant anti-itching and moisturizing properties against varieties of dry skin conditions in the patients of all age groups. However, long-term studies can better clarify the role of oatmeal moisturizer in dry skin conditions.

Full text

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
DERMATOLOGY
Efficacy and Tolerability of an Oatmeal Moisturizer
Containing Colloidal Oatmeal for Dry Skin Conditions:
A Post-marketing Study
VARSHA NARAYANAN*, ANIL GANJOO†, GANESH KADHE‡
ABSTRACT
Background: Skin dryness is a common condition that represents signicant change in the outermost layer of the epidermis
of the skin. Oatmeal moisturizer therapy plays an important role in treating various skin diseases. Methodology/Principal
ndings: The study included a total of 528 patients aged 2-65 years with atopic dermatitis/xerosis, eczema, acne, psoriasis and
other types of skin infections. The patients were treated with oatmeal moisturizer (Nourish Oat) for a duration of 8 weeks. All
the patients were evaluated with modied Kligman grading scale, before and aer the end of therapy. There was a signicant
improvement (p < 0.05) with an increase in the mean dierence in dryness scores from baseline to the end of each treatment
interval (2 weeks- 0.88, 4 weeks- 1.43, 6 weeks- 1.77 and 8 weeks- 1.93). The mean dierences in itching scores from baseline to
the end of treatment were 0.09 aer 2 weeks (p < 0.05), 1.66 aer 4 weeks (p < 0.05), 0.09 aer 6 weeks (p < 0.22) and 1.66 aer
8 weeks (p < 0.05). Overall, 53% and 59% patients had reduced dryness >60% and reduced itching, respectively aer 4 weeks
of treatment period and 89% and 93% patients had reduced dryness >80% and reduced itching, respectively at the end of 8
weeks. No serious skin reactions were reported. Conclusion: Nourish Oat shows good tolerability, ecacy and demonstrates
signicant anti-itching and moisturizing properties against varieties of dry skin conditions in the patients of all age groups.
However, long-term studies can beer clarify the role of oatmeal moisturizer in dry skin conditions.
Keywords: Xerosis, atopic dermatitis, pruritus, dryness, itching
*Head, Medical Affairs
Wockhardt Ltd., Mumbai, Maharashtra
†Senior Consultant
Dermatovenereologist and Laser Surgeon, Delhi
‡Additional Vice President - Medical
Wockhardt Ltd., Mumbai, Maharashtra
Address for correspondence
Dr Varsha Narayanan
Head, Medical Affairs, Wockhardt Ltd., Wockhardt Towers, Bandra Kurla Complex,
Bandra (East), Mumbai - 400 051, Maharashtra
E-mail: VNarayanan@wockhardt.com
Dryness of the skin, also called xerosis is a
common condition which represents signicant
change in the stratum corneum (outermost
layer of the epidermis) of the skin.1,2 The consequence
of the dry skin includes impairment in barrier function,
inammation of the skin and loss of suppleness that
leads to the cracking of skin. It is multifactorial and
may be acquired, constitutional and genetic in origin.1
Adverse events (AEs) such as chances of occurrence
of dermatitis or discomfort on application (with
emollients),3,4 thinning of the skin (anti-inammatory
agents/corticosteroids)5 and skin irritation and burning
(calcineurin-inhibitors)6 have been reported. Menthol,
topical doxepin, topical naltrexone and topical retinoids
may also cause allergic contact dermatitis and in greater
concentration can cause burning and erythema of the
skin.7,8
Soothing eect of colloidal oatmeal and its skin
protecting properties make it an eective option in
treating skin infections including atopic dermatitis and
pruritus.9 The US Food and Drug Administration (FDA)
in 1989 accepted that oatmeal extract is a category 1
(safe and eective) ingredient for skin products.10 The
safety and ecacy of oatmeal moisturizers has been
proven previously in numerous clinical studies in
infants, children and individuals of all age groups.11,12
The aim of the present study was to evaluate the
post-marketing ecacy and tolerability of oatmeal
moisturizer containing colloidal oatmeal (Nourish
Oat) in patients with atopic dermatitis/xerosis, eczema,
acne, psoriasis and other types of dry skin conditions
through a feedback post-marketing survey.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
MATERIALS AND METHODS
Study Population
Subjects (male or female) aged 2-65 years with atopic
dermatitis/xerosis, eczema, acne, psoriasis and other
types of skin infections; and willing to give an informed
consent were enrolled in the study. Subjects with an
allergy to any of the product ingredients, having any
uncontrolled medical illness such as diabetes mellitus,
hypertension, liver disease or history of alcoholism,
human immunodeciency virus (HIV), hepatitis or any
other serious medical illness were excluded. Pregnant
women or nursing mothers were also excluded from
the study.
Study Design
The study was an open-labeled, feedback, phase IV
(post-marketing) trial conducted on 528 subjects for
a duration of 8 weeks. All the patients were advised
to apply the oatmeal moisturizer once- or twice-
daily, depending on the severity of the condition for a
period of 8 weeks. All the subjects were observed and
examined for their vital signs and symptoms before
and aer using the moisturizer. Skin hydration, sebum
levels and transepidermal water loss, constitutive loss
of water from the skin surface were assessed before and
aer the treatment.
The primary outcome variables in the study were the
improvements in dryness and itching in the patient.
The improvement in patients’ symptoms and evaluation
of challenge patch test reactions were assessed with
modied Kligman grading scale. The scores in the scale
are in range from 0 to 3 for dryness (0- healthy skin
with no evidence of dryness even on scratching; 1- mild
dryness on scratching; 2- moderate dryness, small dry
akes or visible whitening of dermatoglyphic triangles
without scratching and 3- severe - well-dened xerosis
with the dermatoglyphic triangles uplied and redness
are readily apparent) and itching (0- no itching of the
skin; 1- mild interference of disease with the quality,
work and social life of an individual; 2- moderate
interference of itching and 3- severe interference of
itching). The secondary outcome variable included
global assessment by the patient and the investigator.
Safety/tolerability was assessed on the basis of AEs
experienced by the patients during or aer the end of
treatment period.
Statistical Analysis
Descriptive statistics were used to summarize the data.
Paired t-test was used to compare the average scores
at baseline and at the end of 8 weeks. The dierence
in mean scores at baseline and at the end of 8 weeks
was compared for itching and dryness. A p-value
<0.05 was deemed signicant. SPSS version 19.0 (IBM
Corporation, United States) soware was used for
statistical analysis.
RESULTS
A total of 528 subjects with various types of skin
infections were enrolled in the study (Fig. 1). The
patients were diagnosed provisionally on the basis
of previous exposure to dry heat, air-conditioned
exposures, substance use, their present medication,
systematic complaints and the family history of skin
diseases. Of these, 206 (39%) patients applied the
oatmeal moisturizer alone while, 322 (61%) patients
applied the oatmeal moisturizer with a co-prescription.
Efficacy
All the patients showed an improvement in their
symptoms at the end of treatment. The overall Kligman
score for dryness for the patients was 2 at baseline that
reduced to 1.4 aer 2 weeks, 0.9 aer 4 weeks, 0.5 aer
6 weeks and 0.3 at the end of 8 weeks. There was a
signicant improvement (p < 0.05) with an increase in
the mean dierence in scores from baseline to the end
of each treatment interval (2 weeks- 0.88, 4 weeks- 1.43,
6 weeks- 1.77 and 8 weeks- 1.93). Similarly, itching was
reduced in all the patients at the end of the therapy; the
overall score of the patients are presented in Figure 2.
The mean dierences in scores from baseline to the
end of treatment were signicant (p < 0.05) aer each
treatment interval and are shown in Table 1.
The average patient satisfaction scores for reduced
dryness were 47.9% aer 2 weeks, 72.1% aer 4 weeks,
Atopic dermatitis
(46%)
Eczema (15%)
Acne (7%)
Psoriasis (9%)
Others (23%)
Figure 1. Provisionally diagnosed patients with various types
of skin infections.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
88.6% aer 6 weeks and 94.5% at the end of 8 weeks
(Fig. 3). The mean dierences in scores from baseline to
the end of treatment were 0.09 aer 2 weeks (p < 0.05),
1.66 aer 4 weeks (p < 0.05), 0.09 aer 6 weeks (p < 0.22)
and 1.66 aer 8 weeks (p < 0.05). Overall, 53% patients
had reduced dryness >60% aer 4 weeks of treatment
period and 89% patients had reduced dryness >80% at
the end of 8 weeks. Similarly, 59% patients had reduced
itching >60% aer 4 weeks of treatment period and
93% had reduced itching >80% at the end of 8 weeks.
The patient satisfaction score for all the symptoms was
achieved for 70.2% patients at the end of 8 weeks.
Table 1. Difference in Scores from Baseline
Parameters Statistical parameters Treatment duration
2 weeks 4 weeks 6 weeks 8 weeks
Dryness N 434 432 431 430
Mean ± SD 0.88 ± 0.79 1.43 ± 0.83 1.77 ± 0.89 1.93 ± 0.81
P value 0.00 0.00 0.00 0.00
Itching N 397 396 395 394
Mean ± SD 0.92 ± 0.85 1.43 ± 0.88 1.77 ± 0.83 1.84 ± 0.88
P value 0.00 0.00 0.00 0.00
Patient satisfaction scores N 430 252 212 109
Mean ± SD -0.96 ± 1.60 -0.52 ± 1.69 0.09 ± 1.80 1.66 ± 1.24
P value 0.00 0.00 0.22* 0.00
Total score N 369 368 367 366
Mean ± SD 1.65 ± 1.46 2.67 ± 1.58 3.29 ± 1.57 3.46 ± 1.56
P value 0.00 0.00 0.00 0.00
Table 2. Adverse Events Observed in Patients During the Study
Duration Number of patients
Stickiness (%) Irritation/burning (%) Redness (%) Odor (%)
2 weeks 29 (5.5) 29 (5.5) 25 (4.7) 29 (5.5)
4 weeks 21 (4.0) 14 (2.7) 11 (2.1) 10 (2.0)
6 weeks 18 (3.4) 9 (1.7) 10 (2.0) 11 (2.1)
8 weeks 18 (3.4) 7 (1.3) 10 (2.0) 4 (0.8)
N = Number of patients, nonsignicant.
Dryness
2
1.4
1.8
1.2
0.7 0.7
0.9
1.5
2.5
3.7
0.4
0.3
0.9
0.6
0.4
Baseline 2 weeks 4 weeks 6 weeks 8 weeks
0
0.5
1
1.5
2
2.5
3
3.5
4
Patient scores
Itching Total score a. Dryness
48
72
89
95
54 51
75
9195
76
9196
2 weeks 4 weeks 6 weeks 8 weeks
0
20
30
10
40
50
60
70
80
90
100
110
120
Patient scores
b. Itching Total score (a + b)
Figure 2. Improvement in patients symptoms along with
the treatment period.
Figure 3. Parametric satisfaction scores of patients.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
Safety
There were no serious or life-threatening AEs observed
in the study. Common and mild AEs included stickiness,
irritation/burning, redness and odor (Table 2). Overall,
29 patients reported stickiness from the moisturizer
aer 2 weeks and the number of patients reporting
stickiness was reduced to 18 at the end of treatment.
Similarly, a total of 29 patients reported odor aer
2 weeks and only 4 patients reported odor at the end
of treatment.
DISCUSSION
The results of this open labeled, phase IV (post-marketing)
feedback trial show that the oatmeal moisturizer is well-
tolerated and ecacious in the treatment of patients
with numerous dry skin conditions. The improvement
in patients scores were observed aer application
of oatmeal moisturizer for all the symptoms of skin
infection such as atopic dermatitis, xerosis, eczema,
acne, psoriasis, etc. Itching is reported as the primary
symptom of numerous dermatological diseases such as
lichen simplex, lichen planus, atopic dermatitis, etc.12,13
In response to this, scratching provides an instant relief
by stimulating mechanical nociceptors, nonetheless it
again exacerbates the condition by encouraging further
lesions in the skin.14 Numerous topical medications are
used but universally no accepted therapy is available.15
The colloidal oatmeal is prepared by removing the
hulls from beans, which contain groat or kernel in it.
According to the US pharmacopeia, the colloidal
oatmeal is dened as the powder obtained aer grinding
and processing of whole oat grain.16 Oat comprises
of avonoids, phospholipids, sterols which exhibit
moisturizing eect and emollient activity. Flavonoids
(phenolic compounds) have anti-inammatory,
antioxidant and antipruritic properties and reduce
the formation of free radicals from lipids.17 They also
inhibit the synthesis of prostaglandins (a mediator of
itching) via anti-inammatory and lenitive actions.18
One of the phenolic compounds, avenanthramides
present in the oats exhibit antioxidant activity in various
cell types. They inhibit the intracellular adhesion
molecule-1 (ICAM-1), vascular adhesion molecule-1
(VCAM-1), and E-selectin that decrease the level of
cytosolic phospholipase A2 in keratinocytes. This leads
to a reduction in the secretion of pro-inammatory
cytokines (tumor necrosis factor [TNF]-α, interleukin
[IL]-8, monocyte chemoaractant protein [MCP]-1 and
histamine) via, nuclear factor kappa B (NFKβ) pathway
in keratinocytes.17
The oatmeal exhibits anti-inammatory transforming
growth factor β1 (TGFβ1) via keratinocytes, which
inhibits the production of ILs.19 It is reported that the
activity of arachidonic acid, cystolic phospholipase
and importantly TNF-α gets decreased with the
oatmeal extract. Aer its inhibition, histamine and pro-
inammatory cytokines are released and inhibit the
TNF-α induced NFKβ luciferase activity, which hinders
systemic inammation.20
Additionally, the soothing eect of oatmeal and its
skin shielding properties make it an ecient option for
treating numerous types of skin diseases.7 Moreover,
oatmeal possesses insoluble proteins (having buering
properties) that help in maintaining pH of the skin.21
Oats are rich in lipids and majority of them are
unsaturated fay acids (having antioxidant property),
which prevent the oxidation of lipids. The activity of
antioxidation is stimulated by phenolic esters, especially
glyceryl esters, which moisturize the skin by their
humectant hydration action.10,22 In addition to these,
linoleic acid, proteins and carbohydrates present in
oats show multifaceted properties in skin conditioning,
cell regeneration, stimulating and anti-inammatory
activities. The oatmeal moisturizer has shown
encouraging results in the past for numerous types
of skin conditions associated dry skin and itching.23,24
A study by Reynertson and colleagues demonstrated
the benets of colloidal oatmeal skin protectant lotion
in 29 healthy female subjects with bilateral mild-to-
moderate itching due to dry skin on their lower legs.
Aer treatment, it was observed that the colloidal
oatmeal extract reduced pro-inammatory cytokines
in vitro and remission in all the clinical signs such as
skin dryness, scaling, roughness and itch intensity
was observed.23 Another study by Vié and colleagues
demonstrated modulating eects of oatmeal extracts in
the sodium lauryl sulfate skin irritancy model. Overall,
12 subjects were pretreated with oatmeal extracts for
2 hours with one side le untreated. The application
of 1% sodium lauryl sulfate with oatmeal extract was
applied for 24 hours. The results displayed a signicant
(p < 0.05) reduction in skin irritation in the model.25
Matheson conducted an assessor blind clinical trial in
35 patients with itching due to sustained burn injuries.
Aer application of a product containing 5% colloidal
oatmeal twice-daily for 10 months, the author reported
a signicant reduction in itching and signicantly
less antihistamine request than those using the oil
containing liquid paran (p < 0.001). Overall, the
patients using liquid paran reported daily mean itch
of at least twice as much intensity as compared to those
using colloidal oatmeal.26

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
Criquet and colleagues demonstrated the safety and
ecacy of colloidal oatmeal products by conducting 12
independent studies in two countries (10 studies in US
and 2 studies in Romania). Of 2,291 subjects, low level
reactions were reported in 1.0% of subjects during the
induction phase of repeat insult patch testing; only one
subject developed low level reaction during challenge
phase in repeat insult patch testing. The study
summarized that the oatmeal containing products
possess low irritant and low allergenic sensitization
potential. The colloidal oatmeal cosmetic care products
were also highly ecacious. Skin hydration, appearance
of squamae and skin roughness were signicantly more
improved than on the control area at all time points for
those using the oatmeal product, including at 2 weeks
aer cessation of application as compared with the
baseline.27
The studies conducted among infants, children and
adults (with atopic dermatitis) containing colloidal
oatmeal products assure its safety and tolerability.28
Nollent et al conducted 12-week open, multicentric
study in Greece, Portugal and Italy among 99 subjects
of ages 6 months to adulthood with atopic dermatitis.
Of 99 subjects, 71 completed the study. Aer treatment
with moisturizer containing oatmeal extracts, a
signicant (p < 0.05) improvement in skin condition
parameters was observed. Overall, 100% improvement
was observed by the patients in skin hydration, 75%
improvement in redness, 68% improvement in scaling,
65% improvement in dryness and 64% improvement
in itching. Interestingly, it was also observed that 63%
population aer the therapy used fewer corticosteroids
in their daily life.12
Kyriakos in the year 2012 presented a preliminary
safety data of oatmeal in children aged 2 months to 16
years at European Society for Pediatric Dermatology
Congress, Istanbul. Overall, 1607 patients were enrolled
in the study with mild-to-moderate eczema with or
without the use of topical steroids. The evaluation
of the scores were assessed with Investigator Global
Assessment (IGA), self-assessment and by quality-of-
life questionnaires. Aer 8-week treatment period with
oatmeal moisturizing cream, a signicant improvement
in IGA scores was observed (p < 0.01). It was observed
that 78% of patients felt less need for use of medication
aer second visit. Overall, 98% of patients reported
a good tolerability prole of the moisturizing cream
containing oatmeal.12 Some of the previous studies
suggested that the persistent use of oatmeal containing
products might lead to oat sensitization specically in
children under 2 years of age but the data has been
contrasting. In a study of 302 children with atopic
dermatitis, atopy patch tests (APT) and skin prick
tests (SPT) to oat proteins were positive in 14.6% and
19.2% of cases, respectively. The children less than
2 years of age were more aected as compared with
the older age group. The authors recommended not
using oatmeal products before the age of 2 years in
predisposed children.29 However, in a double-blind,
randomized patch study of 65 children aged 6 months
to 2 years, no immediate urticarial or allergic reactions
were observed in children aer application of 0.007%
colloidal oats. The authors concluded that colloidal oats
could be used as an adjunct in the management of mild
atopic dermatitis in children under 2 years of age.30 In
another study, the authors reported a low frequency
(2.9%) of oat sensitivity in 202 atopic children who
were oat cream users that was comparable with 2.1%
of those who had never used oat cream.18 Criquet et
al also reported a low allergenic potential on repeat
insult patch testing in a series of studies in patients (18-
69 years) using colloidal oatmeal containing skin care
products. During a 3-year period, 4,45,820 consumers
using the oatmeal skin care products did not have
any allergic reaction.27 In the present study, we tested
the ecacy and tolerability of oatmeal moisturizer
containing colloidal oatmeal and observed a signicant
reduction in the symptoms of patients.
The AEs were few and mild. None of the patients
developed persistent erythema or sensitization to the
product. Further, our study included a heterogeneous
group of patients ranging from 2 months to 65 years;
but none of them reported any untoward reaction.
However, our study has certain shortcomings. This
was a feedback survey based on baseline and end of
treatment session observations. However, like other
feedback surveys it tends to exclude other explanations
for the eect observed. Further, no test group was
included in the study and the study was of short
duration (i.e., 8 weeks). Future well-designed long-term
follow-up studies can further clarify the role of oatmeal
moisturizer in patients with dry skin conditions.
CONCLUSION
Summarizing, the oatmeal moisturizer shows good
tolerability, ecacy and demonstrates signicant anti-
itching and moisturizing properties against varieties
of skin infections in the patients of all age groups.
“Oatmeal nourish” moisturizer might therefore be
considered as a competent application for the treatment
of patients with atopic dermatitis/xerosis, eczema, acne,
psoriasis and other types of dry skin conditions.
Acknowledgment
The author acknowledges Knowledge Isotopes (
www.
knowledgeisotopes.com
) for writing this article and
subsequently revising it by addressing author comments.

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