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Efficacy and Tolerability of an Oatmeal Moisturizer Containing Colloidal Oatmeal for


Dry Skin Conditions: A Post-marketing Study

Article · June 2016

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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 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.
Keywords: Xerosis, atopic dermatitis, pruritus, dryness, itching

D
ryness of the skin, also called xerosis is a agents/corticosteroids)5 and skin irritation and burning
common condition which represents significant (calcineurin-inhibitors)6 have been reported. Menthol,
change in the stratum corneum (outermost topical doxepin, topical naltrexone and topical retinoids
layer of the epidermis) of the skin.1,2 The consequence may also cause allergic contact dermatitis and in greater
of the dry skin includes impairment in barrier function, concentration can cause burning and erythema of the
inflammation of the skin and loss of suppleness that skin.7,8
leads to the cracking of skin. It is multifactorial and
Soothing effect of colloidal oatmeal and its skin
may be acquired, constitutional and genetic in origin.1
protecting properties make it an effective option in
Adverse events (AEs) such as chances of occurrence treating skin infections including atopic dermatitis and
of dermatitis or discomfort on application (with pruritus.9 The US Food and Drug Administration (FDA)
emollients),3,4 thinning of the skin (anti-inflammatory in 1989 accepted that oatmeal extract is a category 1
(safe and effective) ingredient for skin products.10 The
safety and efficacy of oatmeal moisturizers has been
proven previously in numerous clinical studies in
*Head, Medical Affairs infants, children and individuals of all age groups.11,12
Wockhardt Ltd., Mumbai, Maharashtra
†Senior Consultant
The aim of the present study was to evaluate the
Dermatovenereologist and Laser Surgeon, Delhi
‡Additional Vice President - Medical post-marketing efficacy and tolerability of oatmeal
Wockhardt Ltd., Mumbai, Maharashtra moisturizer containing colloidal oatmeal (Nourish
Address for correspondence
Dr Varsha Narayanan Oat) in patients with atopic dermatitis/xerosis, eczema,
Head, Medical Affairs, Wockhardt Ltd., Wockhardt Towers, Bandra Kurla Complex, acne, psoriasis and other types of dry skin conditions
Bandra (East), Mumbai - 400 051, Maharashtra
E-mail: VNarayanan@wockhardt.com through a feedback post-marketing survey.

1118 Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
DERMATOLOGY

MATERIALS AND METHODS at baseline and at the end of 8 weeks. The difference
in mean scores at baseline and at the end of 8 weeks
Study Population was compared for itching and dryness. A p-value
<0.05 was deemed significant. SPSS version 19.0 (IBM
Subjects (male or female) aged 2-65 years with atopic
Corporation, United States) software was used for
dermatitis/xerosis, eczema, acne, psoriasis and other
statistical analysis.
types of skin infections; and willing to give an informed
consent were enrolled in the study. Subjects with an RESULTS
allergy to any of the product ingredients, having any
uncontrolled medical illness such as diabetes mellitus, A total of 528 subjects with various types of skin
hypertension, liver disease or history of alcoholism, infections were enrolled in the study (Fig. 1). The
human immunodeficiency virus (HIV), hepatitis or any patients were diagnosed provisionally on the basis
other serious medical illness were excluded. Pregnant of previous exposure to dry heat, air-conditioned
women or nursing mothers were also excluded from exposures, substance use, their present medication,
the study. systematic complaints and the family history of skin
diseases. Of these, 206 (39%) patients applied the
Study Design oatmeal moisturizer alone while, 322 (61%) patients
The study was an open-labeled, feedback, phase IV applied the oatmeal moisturizer with a co-prescription.
(post-marketing) trial conducted on 528 subjects for
Efficacy
a duration of 8 weeks. All the patients were advised
to apply the oatmeal moisturizer once- or twice- All the patients showed an improvement in their
daily, depending on the severity of the condition for a symptoms at the end of treatment. The overall Kligman
period of 8 weeks. All the subjects were observed and score for dryness for the patients was 2 at baseline that
examined for their vital signs and symptoms before reduced to 1.4 after 2 weeks, 0.9 after 4 weeks, 0.5 after
and after using the moisturizer. Skin hydration, sebum 6 weeks and 0.3 at the end of 8 weeks. There was a
levels and transepidermal water loss, constitutive loss significant improvement (p < 0.05) with an increase in
of water from the skin surface were assessed before and the mean difference in scores from baseline to the end
after the treatment. of each treatment interval (2 weeks- 0.88, 4 weeks- 1.43,
6 weeks- 1.77 and 8 weeks- 1.93). Similarly, itching was
The primary outcome variables in the study were the
reduced in all the patients at the end of the therapy; the
improvements in dryness and itching in the patient.
overall score of the patients are presented in Figure 2.
The improvement in patients’ symptoms and evaluation
The mean differences in scores from baseline to the
of challenge patch test reactions were assessed with
end of treatment were significant (p < 0.05) after each
modified Kligman grading scale. The scores in the scale
treatment interval and are shown in Table 1.
are in range from 0 to 3 for dryness (0- healthy skin
with no evidence of dryness even on scratching; 1- mild The average patient satisfaction scores for reduced
dryness on scratching; 2- moderate dryness, small dry dryness were 47.9% after 2 weeks, 72.1% after 4 weeks,
flakes or visible whitening of dermatoglyphic triangles
without scratching and 3- severe - well-defined xerosis
with the dermatoglyphic triangles uplifted and redness
are readily apparent) and itching (0- no itching of the
skin; 1- mild interference of disease with the quality, Others (23%)

work and social life of an individual; 2- moderate


Psoriasis (9%)
interference of itching and 3- severe interference of Atopic dermatitis
itching). The secondary outcome variable included Acne (7%)
(46%)

global assessment by the patient and the investigator.


Eczema (15%)
Safety/tolerability was assessed on the basis of AEs
experienced by the patients during or after the end of
treatment period.

Statistical Analysis
Descriptive statistics were used to summarize the data. Figure 1. Provisionally diagnosed patients with various types
Paired t-test was used to compare the average scores of skin infections.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016 1119
DERMATOLOGY

88.6% after 6 weeks and 94.5% at the end of 8 weeks period and 89% patients had reduced dryness >80% at
(Fig. 3). The mean differences in scores from baseline to the end of 8 weeks. Similarly, 59% patients had reduced
the end of treatment were 0.09 after 2 weeks (p < 0.05), itching >60% after 4 weeks of treatment period and
1.66 after 4 weeks (p < 0.05), 0.09 after 6 weeks (p < 0.22) 93% had reduced itching >80% at the end of 8 weeks.
and 1.66 after 8 weeks (p < 0.05). Overall, 53% patients The patient satisfaction score for all the symptoms was
had reduced dryness >60% after 4 weeks of treatment 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
N = Number of patients, ⃰nonsignificant.

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)

Baseline 2 weeks 4 weeks 6 weeks 8 weeks 120 2 weeks 4 weeks 6 weeks 8 weeks
4 110
3.7
100 95 96 95
3.5 89 91 91
90
3 80 76 75
Patient scores

72
Patient scores

2.5
2.5 70
2 60 54
2 1.8 51
50 48
1.4 1.5
1.5 40
1.2
1 0.9 0.9 30
0.6 0.7 0.7
20
0.5 0.4 0.4
0.3 10
0 0
Dryness Itching Total score a. Dryness b. Itching Total score (a + b)

Figure 2. Improvement in patients symptoms along with Figure 3. Parametric satisfaction scores of patients.
the treatment period.

1120 Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
DERMATOLOGY

Safety The oatmeal exhibits anti-inflammatory transforming


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

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016 1121
DERMATOLOGY

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

1122 Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016
DERMATOLOGY

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