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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%)
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.
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
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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
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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016 1123