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Safety and efficacy of personal care products containing colloidal oatmeal

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Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.
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Clinical, Cosmetic and Investigational Dermatology 2012:5 183–193
Clinical, Cosmetic and Investigational Dermatology
Safety and efcacy of personal care products
containing colloidal oatmeal
Maryline Criquet1
Romain Roure1
Liliane Dayan²
Virginie Nollent1
Christiane Bertin1
1Johnso n & Johnson SanBeauté
France, Issy les Moulineaux,
²Independent consultant
dermatologist, Paris, France
Correspondence: Christiane Bertin
Johnson & Johnson Santé Beauté
France, 1, rue Camille Desmoulins,
92787 Issy-les-Moulineaux, France
Tel +331 5500 4733
Email cbertin@its.jnj.com
Background: Colloidal oatmeal is a natural ingredient used in the formulation of a range of
personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive
product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of
particular importance and the risk of developing further skin irritations and/or allergies should
be minimized.
Methods: In a series of studies, we tested the safety of personal care products containing oatmeal
(creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch
testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin.
We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care
product for dry skin.
Results: We found that oatmeal-containing personal care products had very low irritant potential
as well as a very low allergenic sensitization potential. Low-level reactions were documented in
1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects
developed a persistent but doubtful low-level reaction involving edema during the challenge
phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch test-
ing after in-use application. Sustained skin moisturizing was documented in subjects with
dry skin that lasted up to 2 weeks after product discontinuation.
Conclusion: Our results demonstrate that colloidal oatmeal is a safe and effective ingredient
in personal care products. No allergies were reported by consumers of 445,820 products sold
during a 3-year period.
Keywords: Avena sativa, colloids, protective agents, atopic dermatitis, irritant dermatitis,
allergenic dermatitis, skin care
Introduction
Colloidal oatmeal is a natural product derived from oat grains (Avena sativa) that have
been ground into a very fine powder, with a complex chemical composition including
polysaccharides, lipids, proteins, flavonoids, minerals, and vitamins.1 Colloidal oatmeal
is appreciated for its moisturizing, cleansing, antioxidative, and anti-inflammatory prop-
erties, which are conferred by its chemical heterogeneity. A variety of oatmeal-containing
personal care products are available, including bath products, shampoos, moisturizers,
and shaving foams, for the protection and alleviation of, eg, rashes and dry skin, and
for cleansing and moisturizing.2 Used as adjunctive therapy in infants with moderate-
to-severe atopic dermatitis, it can help to reduce the need for high-potency topical
corticosteroids.3 The anti-irritant effects of colloidal oatmeal appear to be mediated
by avenanthramides, which inhibit immune-dependent skin inflammation.4
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Clinical, Cosmetic and Investigational Dermatology 2012:5
Epidemiological studies have shown that a high number
of individuals suffer from sensitive skin, with a prevalence
of 51%–52% in women and 38% in men.5,6 Symptoms of
cosmetic-induced skin discomfort, such as burning, stinging,
and itching, are reported more commonly by individuals
with sensitive skin than by those who consider themselves
nonsensitive.6 Fragrances and preservatives are the most
frequently identified allergenic sensitizers in cosmetic
dermatitis.7 The inclusion of food proteins in personal care
products is controversial in terms of whether topical applica-
tion of oatmeal-containing products induces percutaneous
sensitization in subjects with atopic dermatitis and to what
extent.8–10
Therefore, it is of the utmost importance that personal
care products, in particular those intended to treat sensitive
skin or to help in the treatment of atopic dermatitis, do not
aggravate existing skin conditions and that the risk of allergic
reactions is minimized by excluding sensitizing ingredients.
We sought to determine the irritant and allergenic potential
of a range of personal care products containing colloidal
oatmeal as an active ingredient after repeated applications
in human subjects including those with sensitive skin or a
history of atopic dermatitis. We also assessed the efficacy of
an oatmeal-containing cream in relieving skin dryness.
Safety assessment
Repeat insult patch tests
Twelve independent studies were performed at two centers
in two countries (10 studies in the US, and two studies in
Romania) between February 2000 and May 2009. The tests
were conducted under the supervision of a dermatologist who
participated in the evaluation of irritation/allergic reactions to
the test materials. Each panel comprised 114–245 male and
female volunteers who gave their written informed consent
before enrolment. Subjects with dermatological or other
medical or physical conditions precluding topical application
of the test material, were excluded, along with pregnant and
nursing women. The study centers used different protocols.
For the induction period, a series of nine induction patchings
were performed over a period of 3 weeks.
The materials tested were 12 skin care products contain-
ing oatmeal as the active ingredient. These comprised three
lotions, two face creams, one serum product, two cleansing
lotions, one exfoliating cleanser, two baby products (one
cream and one cleanser), and one hand cream.
At the US site, an occlusive or semiocclusive patch
containing 0.2 g of test material was applied to the left side
of the back where it remained for 24 hours. Subjects were
instructed to keep the patch as dry as possible and to remove
it after 24 hours. No test material was applied for the follow-
ing 24 (on weekdays) or 48 hours (on weekends), after which
evaluation for potential dermal reactions was undertaken.
Reactions after patching were scored according to a modi-
fied version of the International Contact Dermatitis Research
Group scoring system11 (see Table 1).
At the Romanian site, patches containing 25 µL of the test
material were applied to the back in a semiocclusive manner
and removed after 48 hours. The dermal response during this
period was scored using a five-point scale (see Table 1). The
rest period comprised 2 weeks without application of the test
material. During the challenge period, patches were prepared
and fixed in the same manner as in the induction period, but
on the right side of the back (ie, a virgin site).
The patches were removed after 24 hours at the US
study center, and scoring of skin reactions was performed
in the same manner as before at 24, 48, 72, and 96 hours
after patching. At the Romanian study center, the patches
remained in place for 48 hours and skin reactions were
scored 30 minutes and 24 and 48 hours after patch removal
using the International Contact Dermatitis Research Group
scoring system.
Table 1 Scoring methods used for evaluation of irritation/allergic
skin reaction
Grade Description
US studies: induction period and challenge period
(ICDRG-modied scoring scale for dermatitis11)
0 No visible reaction
±Faint, minimal erythema
1 Erythema
2 Intense erythema, induration
3 Intense erythema, induration, vesicles
4 Severe reaction with erythema, induration,
vesicles, pustules (including weeping)
E Indicates presence of edema
Romanian studies: induction period
No evidence of any effect
1 Mild (pink, uniform erythema)
2 Moderate (pink-red erythema)
3 Marked (bright red erythema with/without
petechiae or papules)
4 Severe (deep red erythema with/without
vesiculation or weeping)
Romanian studies: challenge period (ICDRG scoring scale)
– Negative
+?Doubtful reaction (slight erythema)
+Weak reaction (nonvesicular reaction)
++ Strong reaction (erythema, edema, and/or vesicles)
+++ Severe reaction with blisters
Abbreviation: ICDRG, International Contact Dermatitis Research Group System.
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Safety-in-use tests
Twelve independent studies were performed at four study
centers in four countries (seven studies in the UK, two in
Poland, two in Germany, and one in Bulgaria) between April
2006 and August 2009. Subjects with a range of self-reported
skin types and sensitivities were recruited. In the UK studies,
the test materials were applied for 7, 10 or 28 days and skin
reactions were evaluated using self-assessment question-
naires (adverse reaction, yes/no, severity slight, moderate,
severe). The studies conducted in Poland involved a 3-week
application period, with ophthalmological assessment by
slit-lamp and evaluation of subjective functional signs before
and after use on day 21 and subjective self-assessment
patient questionnaires regarding functional/physical signs.
The Bulgarian study involved 3 weeks of application, with
dermatological evaluation (detection of allergy, irritation,
dryness, discomfort, pimples) and subject self-assessment
questionnaires (adverse reaction, yes/no). The studies in
Germany included a 4-week application period in adults
and children followed by occlusive patch testing in the adult
participants. Reactions during the application period and after
patch testing were evaluated by a dermatologist-allergologist
at 24, 48, and 72 hours after patching. The following test
materials were used: shower and bath oil, cream, moistur-
izing oil, shower gel, night cream, conditioning shampoo,
body lotion, liquid hand wash, face and eye cleansing lotion
(two products), facial exfoliating cleanser, intimate wash,
and baby milk.
Efcacy assessment
An open prospective study was performed to assess the effect
of an oatmeal-containing body cream on various aspects
of dry skin. Fifty female subjects aged 20–67 years were
enrolled. All subjects were of Caucasian origin and had dry
to very dry skin of phototype I–IV. The study duration was
6 weeks, which included 4 weeks of study product application
followed by 2 weeks without product application. Subjects
were instructed to avoid use of other skin care products,
with the exception of cleansers, for 3 days before starting
the study, as well as for 2 weeks following the study period.
The study product was to be applied once a day in the morn-
ing on the leg (external part of the calf) and on the inner
forearm according to the subjects’ usual application habits.
Assessments were performed at baseline, and on days 1, 14,
and 28, and 2 weeks after the last application (day 42). Skin
hydration (moisture content in the upper epidermis) was
assessed using a Corneometer® CM 825 (Courage + Khazaka
Electronic GmbH, Germany). The mean of three consecutive
measurements was calculated. The desquamation index and
the surface area of dead epithelial cells were assessed using
adhesive disc stripping (D-squame®; CuDerm Corporation,
Dallas, TX) with subsequent digital image analysis.
Clinical efficacy was assessed by a dermatologist.
Assessments included visual examination of skin dryness and
appearance of epithelial squamae, as well as tactile evaluation
of skin roughness. A 10 cm visual analog scale was used,
where 0 represented “none” and 10 was “severe”. Subject
self-assessment involved a questionnaire with a five-point
scale ranging from 1 (“agree”) to 5 (“disagree”). The number
of responses from category 1 and 2 (ie, “agree” and “rather
agree”) was combined for analysis. Measurements were
made on the treated body areas (leg and inner forearm), as
well as on an untreated area on the mid-thigh which served
as a control site. Clinical assessments were performed only
on the treated leg and on the control area.
Statistical analysis was performed using SPSS software
(SPSS Inc, Chicago, IL). Data at each assessment time point
are shown as the mean ± standard error of the mean. At each
time point, data were compared with baseline and, where
applicable, the difference between treated and untreated
sites was compared, and the difference was expressed as a
variation percentage. The Student’s paired t-test (for normal
distribution) or the Wilcoxon test (for nonnormal distri-
bution) was used at a significance level of P # 0.05. All
subjects involved in the study gave their written informed
consent before enrolment. All studies described herein were
conducted according to the ethical principles outlined in
the Declaration of Helsinki and according to good clinical
practices.
Results
Safety analysis
Of the 2565 men and women who enrolled in the 12 repeat
insult patch testing studies, 274 discontinued for reasons other
than a reaction to the test material. In the induction period,
a total of 23 patients experienced a reaction. We observed
34 transient low-level grade ± reactions (ie, faint minimal
erythema) in 20 subjects (including one patient with eight
consecutive faint erythema readings), six transient low-level
grade 1 reactions in six subjects, and mild erythema in one
subject. In the challenge period, 17 patients had a reaction.
This comprised 18 transient low-level grade ± reactions in
14 subjects, nine transient low-level grade 1 reactions in
seven subjects, and five grade 1 reactions with edema in three
subjects (Table 2). Edematous reactions were not confirmed
in subsequent patch tests for two subjects. However, for the
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Clinical, Cosmetic and Investigational Dermatology 2012:5
Table 2 Summary of repeat insult patch testing studies
Test material Date/country Participants Application Results
Lotion June–July 2005,
US
245 included/
207 completed
66 male, 141 female
Aged 18–70 years
Occlusive No reaction during induction phase or challenge phase
Conclusion: no potential for dermal irritation or
sensitization
Lotion December 2001–
January 2002, US
226 included/
209 completed
55 male, 154 female
Aged 18–69 years
Occlusive Induction phase: one transient low-level ± reaction in
one subject (reading 1)
Challenge phase: three low-level ± reactions in one
subject (48, 72, 96); one level 1 + edema reaction (72 hours),
one transient low-level reaction (1) in one subject (96 hours)
Remarks: test material did induce an edematous reaction
indicative of dermal sensitization in one human subject
This reaction was not conrmed by a second patch testing
Conclusion: no potential of the product for dermal sensitization
Lotion SPF15 July–August 2001,
US
221 included/
193 completed
55 male, 138 female
Aged 18–69 years
Semiocclusive No reaction during induction phase or challenge phase
Conclusion: no potential for dermal irritation
or sensitization
Cleansing
lotion
February–April 2005,
US
227 included/
206 completed
66 male, 140 female
Aged 18–70 years
Semiocclusive Induction phase: two transient low-level ± reactions in one
subject (readings 1, 2); three transient low-level ± reactions
in one subject (readings 7–9)
Challenge: no reactions
Conclusion: no potential for dermal irritation or sensitization
Cleansing
lotion
February–April 2000,
US
213 included/
183 completed
48 male, 135 female
Aged 18–69 years
Occlusive Induction phase: one transient low-level ± reaction in two
subjects (readings 6, 8); two transient low-level ± reactions
in two subjects (readings 4, 5); four low level transient
reactions (1 × 1; 3 × ±) in 1 subject (readings 2–5)
Challenge phase: one transient low-level reaction (±) in four
subjects (24 hours, 3 × 48 hours); two transient low-level
reactions (1; ±) in one subject (48 hours, 72 hours)
Conclusion: no potential for dermal irritation or sensitization
Cream December 2005–
January 2006, US
240 included/
224 completed
59 male, 165 female
Aged 18–69 years
Occlusive No reaction during induction phase
Challenge phase: one transient low-level reaction (±) in one
subject (48 hours); two transient low-level ± reactions in one
subject (48 hours, 72 hours)
Conclusion: no potential for dermal irritation or sensitization
Night cream July–August 2006,
US
240 included/
217 completed
68 male, 149 female
Aged 18–70 years
Semiocclusive Induction phase: one transient low-level ± reaction in two
subjects (readings 2)
Challenge phase: two transient low-level ± reactions in one
subject (48 hours, 72 hours)
Conclusion: no potential for dermal irritation or sensitization
Serum July–August 2006,
US
240 included/
217 completed
68 male, 149 female
Aged 18–70 years
Semiocclusive Induction phase: one transient low-level ± reaction in three
subjects (readings 2, 9, 9); one transient low-level reaction (1)
in one subject (reading 5); two transient low-level reactions
(1; ±) in one subject (readings 5, 6)
Challenge phase: one level 1 + edema reaction (48 hours),
two low-level transient reactions (1) in one subject
(24 hours, 72 hours); two transient low-level reactions
(1; ±) in one subject (48 hours, 72 hours)
Remark: test material did induce an edematous reaction
indicative of dermal sensitization in one human subject;
reaction not conrmed by a second patch testing
Conclusion: no potential of the product for dermal sensitization
Baby cream February–March 2009,
Romania
114 included/
109 completed
13 male, 96 female
Aged 18–70 years
Semiocclusive Induction phase: one mild erythema (1) in one subject
(reading 3)1
Challenge phase: no reaction
Conclusion: no potential for dermal irritation or sensitization
(Continued)
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Table 2 (Continued)
Test material Date/country Participants Application Results
Handcream May–June 2002,
US
240 included/
201 completed
59 male, 142 female
Aged 18–70 years
Semiocclusive Induction phase: two transient low-level reactions (1; ±)
in one subject (readings 3, 4); eight low-level reactions (±)
in one subject (readings 2–9)
Challenge phase: one transient low-level reaction (±)
in one subject (72 hours); three level 1 + edema reactions
in one subject (48 hours, 72 hours, 96 hours)
Remarks: test material did induce an edematous reaction
indicative of dermal sensitization in one human subject;
reaction conrmed with the nished product by a second
patch testing but not with Avena sativa
Conclusion: doubtful
Exfoliating
cleanser
March–May 2009,
Romania
114 included/
109 completed
23 male, 86 female
Aged 18–68 years
2% dilution,
semiocclusive
No reaction during induction phase or challenge phase
Conclusion: no potential for dermal irritation or sensitization
Wash
(head-to-toe)
August–
September 2007,
US
245 included/
216 completed
59 male, 157 female
Aged 18–70 years
8% dilution,
occlusive
Induction phase: one transient low-level ± reaction in three
subjects (readings 2, 7, 7); one transient low-level reaction
(1) in one subject (reading 2); two transient low-level
reactions (1; ±) in one subject (readings 7, 8)
Challenge phase: two transient low-level reactions (1; ±) in
two subjects (48 hours, 72 hours); three transient
low-level reactions (2 × 1; 1 × ±) in one subject
(48 hours, 72 hours, 96 hours)
Conclusion: no potential for dermal irritation or sensitization
Note: 1Note that different scoring methods were used at the two study sites.
other subject, reactions were confirmed for the complete
product.
A total of 645 subjects were enrolled in the 12 safety-in-use
studies, which were completed by 615 subjects. Seven stud-
ies tested skin reactions to different facial, body, and hair
cleansers as well as creams in female subjects with normal
to very dry skin and skin sensitivity ranging from not sensi-
tive to very sensitive by means of subjective self-evaluation
(UK studies, Table 3). Among the 402 subjects who returned
their questionnaires, 18 reported adverse reactions. The
majority of these reactions (nine) were moderate in nature,
followed by slight (seven) and severe (two) reactions. In
another study, the reaction to a facial cleanser was evalu-
ated in female subjects with normal to oily or dry skin, of
whom 32% had a history of atopic dermatitis. No reaction
was reported by the investigating dermatologist. Two studies
evaluated the ocular tolerance of a facial cleanser in 43 female
subjects with normally sensitive eyes. Eye reactions were
documented in three of the subjects and confirmed by clinical
ophthalmological evaluation, and in nine subjects according
to self-evaluation (Table 4). Finally, two studies tested the
reactions to two test materials in 80 adults and 30 children
with normal to dry skin. A history of atopic dermatitis was
reported for 27 of 80 adults and for 11 of 30 children who
participated in these studies. For adult subjects, the applica-
tion period was followed by a patch test using the diluted or
undiluted product. No clinical reaction was observed during
the application period by any of the 110 subjects nor was
there a reaction after patch testing in the 80 adults.
Efcacy analysis
A total of 47 subjects completed the study of the clinical
efficacy of an oatmeal-containing body cream, with evalu-
ation on day 14, and 46 subjects underwent evaluation on
days 28 and 42.
Skin hydration
On the forearm, skin hydration was significantly higher at all
time points, including at 2 weeks after cessation of applica-
tion (day 42), compared with baseline. For the leg area, an
increase in hydration was observed that was significantly
higher than on the control site at all time points (Figure 1).
Desquamation index and dead cell surface area
The surface area of dead epithelial cells and the epithelial
desquamation index on the forearm were significantly
reduced at all assessment time points compared with
baseline. On the leg, a reduction in the dead cell surface
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Table 3 Summary of safety-in-use studies
Test
material
Date/country Participants Application Result (number of subjects
with reaction/total
number of subjects)
Skin/hair type1 and skin/eye
sensitivity1 (if applicable)
Shower and
bath oil
December 2006,
UK
60 included (dry, very dry body skin),
53 completed (skin sensitivity:
19% not sensitive, 47% a little sensitive,
23% sensitive, 11% very sensitive)
Aged 18–55 years
Female
Use product on seven
consecutive days instead
of usual shower product
Adverse reaction: 3.8%
2/53 (one moderate, one slight)
Cream
moisturizing
oil
December 2006,
UK
60 included (dry, normal to dry body skin),
56 completed (skin sensitivity:
23% not sensitive, 52% a little sensitive,
21% sensitive, 4% very sensitive)
Aged 18–55 years
Female
Use product once a
day on seven
consecutive days
instead of usual
body moisturizer
Adverse reaction: 3.6%
Two of 56
(one severe, one moderate)
Shower gel August 2006,
UK
60 included (dry, sensitive body skin),
59 completed (skin sensitivity
not indicated)
Aged 20–50 years
Female
Use product on seven
consecutive days
instead of usual
shower product
Adverse reaction: 3.4%
Two of 59 (two moderate)
Night cream April–May 2009,
UK
70 included (facial skin: normal,
dry, normal to dry, normal to greasy,
normal/dry/greasy)
64 completed (skin sensitivity:
5% not sensitive, 61% a little sensitive,
30% sensitive, 5% very sensitive)
Aged 25–49 years
Female
Use product on
28 consecutive days
instead of usual
night-time moisturizer
Adverse reaction: 10.9%
Seven of 64 (ve subjects with
slight to moderate reactions,
one subject with moderate to
severe reactions, and one
subject with severe reactions)
Conditioning
shampoo
January–
February 2007, UK
60 included (all hair types)
Male 30, female 30
55 completed
Aged 18–55 years
Use product on
10 occasions,
no use of conditioner
Adverse reaction: 3.6%
Two of 55 (two moderate)
Body lotion November–
December 2006, UK
60 included (dry, normal to dry body skin),
57 completed (skin sensitivity:
12% not sensitive, 39% a little sensitive,
19% sensitive, 30% very sensitive)
Aged 18–55 years
Female
Use product on seven
consecutive days as
frequently as required
Adverse reaction: 0%
Liquid hand
wash
October 2006,
UK
60 included (dry, normal to dry, very dry
hand skin), 58 completed (skin sensitivity:
12% not sensitive, 55% a little sensitive,
22% sensitive, 10% very sensitive)
Aged 18–55 years
Female
Use product on seven
consecutive days as
frequently as required
instead of usual hand
wash product
Adverse reaction: 5.2%
Three of 58 (one slight and
two moderate)
Facial
exfoliating
cleanser
March–April 2009,
Bulgaria
62 included (normal, mixed oily, oily,
mixed dry, dry skin), 60 completed
(sensitive skin 100%, history of
atopy 32%), two withdrew consent
Aged 18–60 years
Female
Use product 1 × per day
on face and neck during
3 weeks
Safety evaluation:
Adverse reactions observed
by dermatologist: 0/60
Adverse reaction reported
by subjects: 3/60
Intimate
wash
January 2007,
Germany
60 included (48% healthy skin,
17% dry skin, 2% sensitive skin,
33% atopic dermatitis/eczema-free
interval), 60 completed
Aged 18–58 years
Female
Use product at least
1 × per day during
4 weeks
Subsequent occlusive
patch test with
1%, 2%, 5% dilutions,
inner forearm for
24 hours
After 4 weeks: adverse reaction: 0
Patch test: no reaction at any
concentration
(Continued)
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Table 3 (Continued)
Test
material
Date/country Participants Application Result (number of subjects
with reaction/total
number of subjects)
Skin/hair type1 and skin/eye
sensitivity1 (if applicable)
Baby milk January 2007,
Germany
20 adults included (25% normal skin,
20% dry skin, 20% sensitive skin,
35% atopic dermatitis/eczema free interval),
20 completed
Aged 21–47 years
Six male, 14 female
30 children included (27% normal skin,
20% dry skin, 17% sensitive skin,
37% atopic dermatitis/eczema free interval),
30 completed
Aged 8 months to 4 years
11 male, 19 female
Use product at least
2 × per day during
4 weeks
Subsequent occlusive
patch test with adults
only (undiluted), inner
forearm for 24 hours
After 4 weeks: adverse reaction: 0
Patch test: no reaction
Note: 1According to information supplied by subject.
area was observed that was significantly larger than that on
the control area at all time points. In this area, the desqua-
mation index also diminished to a significantly greater
extent than in the control area during the application period
(Figure 2).
Clinical evaluation
Throughout the application period, all parameters (skin dry-
ness, appearance of squamae, and skin roughness) assessed
by the dermatologist on the leg were significantly more
improved than on the control area (Figure 3). This was
still the case beyond cessation of treatment on day 42. No
clinically significant adverse reactions were noted during the
course of the study.
Self-evaluation
At days 14 and 28, 63%–100% of the subjects responded
favorably (“agree” or “rather agree”) to a series of questions
concerning subjective evaluation of signs of skin dryness
after application of the product (Figure 4). Two weeks after
cessation of application, the proportion of positive responses
was 40%–61%.
Discussion
We tested the irritation and sensitization potential of
12 oatmeal-containing personal care products in 2291 subjects
as part of a series of repeat insult patch testing studies. We
observed only low-level reactions corresponding to faint
erythema, minimal erythema, or obvious erythema accord-
ing to the scoring system used. All of the subjects concerned
(23/2291, ie, 1.0%) experienced transient reactions, with
the exception of one individual with persistent erythema.
These data indicate a very low irritancy potential for the
study materials. In the subsequent challenge period, we saw
mostly transient low-level reactions (14/2291 subjects, ie,
0.6%). Three subjects had a low-level reaction accompanied
by edema. One of these subjects had a persistent reaction
on three consecutive readings. However, this reaction was
doubtful because it was confirmed with the complete product
and not with A. sativa. The test material in that case was a
Table 4 Summary of ocular tolerability testing under ophthalmological control (safety-in-use studies)
Test material Date/country Participants Application Result (number of subjects
with reaction/per total
number of subjects)
Skin/hair type1 and skin/eye
sensitivity1 (if applicable)
Face and eye
cleansing lotion
September 2009,
Poland
22 included (normally sensitive eyes),
22 completed
Aged 18–70 years
Female
Use product 2 × per day
on face including eye area
and neck during 3 weeks
Clinical signs: 0%
Face and eye
cleansing lotion
September 2009,
Poland
22 included (normally sensitive eyes),
21 completed
Aged 18–60 years
Female
Use product 2 × per day
on face including eye area
and neck for 3 weeks
Clinical signs: 14%
3/21 (possibly attributable to product
and for two subjects only on one eye)
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Colloidal oatmeal in skin care
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40
AB
30
20
10
0
40
50
30
20
10
0
D1
22.2
25.0
17.6
5.6
P = 0.014
P < 0.001
35.4
42.8 43.0
9.8
P = 0.012
P < 0.001 P < 0.001
P < 0.001
P < 0.001
P < 0.001
D14
Forearm
% improvement
% improvement
Leg
D28 D42 D1 D14 D28 D42
Figure 1 Skin hydration increases during and after use of oatmeal-containing cream.
Notes: Hydration of the forearm increased signicantly during the application period (days 1–28) and afterwards (day 42) compared with baseline. Hydration of the leg
increased signicantly more compared with the control area at all time points.
30
AB
CD
P < 0.001
P < 0.001
P < 0.001
Surface of dead cells
Surface of dead cells
Desquamation rate
Desquamation rate
P = 0.002
P < 0.001 P < 0.001
P < 0.001
P < 0.001
P < 0.001
P < 0.001
P < 0.001
P = 0.003
P = 0.046
P = NS
P = 0.037
P = 0.002
11.9
7.6
15.5
14.9
11.1
11.8
15.1
19.3
4.3
17.6
25.0
28.2
4.2
20.7 21.5
8.8
25
20
15
10
5
0
40
35
25
15
10
5
0
30
20
30
25
20
15
10
5
0
40
D1 D14D28
LegLeg
Forearm Forearm
% improvement
% improvement
% improvement
% improvement
D42
D1 D14D28 D42
D1 D14 D28 D42
D1 D14 D28 D42
35
25
20
15
10
5
0
30
Figure 2 Surface area of dead cells and desquamation index diminish with use of oatmeal-containing cream. Surface of dead cells (A) and desquamation rate (B) were
compared with baseline for the forearm area and their reduction is indicated as percentage improvement. Data derived from leg measurements was compared with the
control area for surface of dead cells (C) and desquamation rate (D).
Abbreviation: NS, not statistically signicant.
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100
90
80
70
60
50
40
30
20
10
0
D1 D14
% improvement
D28 D42
P < 0.001
P < 0.001
P < 0.001
P < 0.001
Skin dryness
Appearance of squamae
Skin roughness
59.8
47.8
63.8
50.4
54.8 52.6
65.4 62.6
53.2
12.8 13.6
6.0
Figure 3 Clinically assessed parameters improve with use of oatmeal-containing cream.
Note: At all time points, the three parameters assessed, ie, skin dryness, appearance of squamae, and skin roughness, were signicantly more improved on the treated leg
area compared with the control area.
hand cream. The edematous reaction was transient in the
two other subjects.
Furthermore, we performed safety-in-use testing of
both “leave-on” (creams and lotions) and “wash/rinse-
off (shower oils and shower gels, shampoo, liquid hand
wash, facial cleansers, intimate wash) oatmeal-containing
products to assess their irritancy potential. The majority
of these safety-in-use studies (8/12) included subjects with
self-reported sensitive skin. Three studies also included
subjects with a self-reported history of atopic dermatitis.
The prevalence of sensitive skin among the subjects was
77%–100%, but was lower in two of the studies including
010
Skin looks more moisturized
Skin feels suppler
Skin feels softer
Skin is protected
Skin is repaired
Skin is more comfortable
Skin does not feel tight
Skin is nourished
Product relieves and soothes prickling sensations
Skin is intensively and durably moisturized
Skin is intensively and durably nourished
Skin remains moisturized
Skin remains supple
Skin remains soft
Skin remains comfortable
Skin does not feel tight
Skin is always nourished
Tugging sensations do not appear
Squamae do not reappear
20 30 40
% of positive responses
50 60 70 80 90 100
D42
D28
D14
Figure 4 Subjective evaluation of effect on signs of skin dryness.
Note: The percentage of patients who reported a positive effect on skin dryness is depicted (combination of answers “agree” and “rather agree”).
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Clinical, Cosmetic and Investigational Dermatology 2012:5
atopic subjects (2%–20%). The proportion of subjects
with sensitive skin in our studies was higher than that in
the general population, as indicated by a frequency of
self-reported sensitive skin in a random population sample
in the UK of 51% in women and 38% in men and of 52% in
women in the US.5,6 Of the tests involving self-assessed skin
reactions, the highest percentage of reactions was observed
for a leave-on night cream, which provoked reactions in
7/64 subjects (10.9%), followed by a face and eye cleanser
(two of 22 subjects, 9.1%). Other test materials (mainly wash/
rinse-off products) had a lower frequency of adverse reactions
(0% for a face and eye cleanser and a body lotion, ,4% for
shower oils, gels, and a shampoo, 5% for a facial exfoliating
cleanser, and 5.2% for a liquid hand wash). In one of the two
studies including ophthalmological evaluation after use of a
face and eye cleansing lotion, we observed 14% of clinical
eye signs with possible implication of the product in one case
and reactions only on one eye in two subjects.
For two studies, in which one third of subjects were
atopic, we did not find any clinical signs of skin irritation
in either adults or infants or when assessed, of allergic
sensitization in adults. Atopic dermatitis is an inflammatory
skin condition particularly affecting infants and children.
It appears to be increasing in prevalence,12,13 and affects
10%–20% of individuals in the first decade of life.14 In a
recent study of 67 children with atopic dermatitis, it was
suggested that use of moisturizers containing oat protein
is a risk factor for oat sensitization.8 In the same study,
15% of 302 children aged 4 months to 15 years with atopic
dermatitis had a positive oat extract atopy patch test result
and 19% had a positive skin prick test result. However, the
frequency of oat sensitivity was much lower in another study
performed in 202 atopic children, with sensitivity reported
in 2.9% of children who were oat cream users and in 2.1%
of those who had never used oat cream.9 No sensitization
to topical colloidal oatmeal was found in a randomized,
double-blind study performed in 65 atopic and nonatopic
children between 6 months and 2 years of age.10 In our
studies, we limited patch tests after in-use application of
the test material to adults, and did not observe any allergic
sensitization in 80 participants.
The skin hydrating properties of colloidal oatmeal have
been ascribed to its propensity to form an occlusive film capa-
ble of binding water in the stratum corneum.1 We observed
a significant moisturizing effect of an oatmeal-containing
cream on dry skin throughout the application period, which
was sustained for 2 weeks afterwards. This was indicated by
increased hydration, a reduced desquamation index, and a
reduced surface area occupied by dead skin cells, as well as
by clinical evaluation and subjective self-evaluation.
Conclusion
We demonstrated that the irritation and allergenic potential of
a diverse range of oatmeal-containing personal care products
is low. With the exception of one subject, in whom the reac-
tion to A. sativa was doubtful, more than 2300 subjects did
not show allergic sensitization. Moreover, in allergic patients
we reported by consumers of 445,820 products sold during a
3-year period. In addition, we found a sustainable moistur-
izing effect of oatmeal-containing products on dry skin.
Acknowledgment
The authors thank Beate Gerstbrein for her help in prepara-
tion of the manuscript.
Disclosure
Vincent Walczak and Judith Nebus, both employees of
Johnson & Johnson CPWW, provided information on the
studies mentioned in this paper.
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Colloidal oatmeal in skin care
... who exhibited irritation; it was concluded that these products had a low potential for irritation (Table 8). 92 The concentrations of colloidal oatmeal were not provided. The products tested were a shower and bath oil, cream, moisturizing oil, shower gel, night cream, conditioning shampoo, body lotion, liquid hand wash, face and eye cleansing lotion (2 products), facial exfoliating cleanser, intimate wash, and baby milk. ...
... In 12 HRIPTs (total N ¼ 2,291) performed using 12 skin care products containing Avena Sativa Colloidal Oatmeal, the products did not produce signs of sensitization (Table 9). 92 The test substances comprised 3 lotions, 2 face creams, 1 serum product, 2 cleansing lotions, 1 exfoliating cleanser, 2 baby products (1 cream and 1 cleanser), and 1 hand cream. The ...
... In 2 use studies of a face and eye cleansing lotion containing Avena Sativa Colloidal Oatmeal (concentration not provided), the products caused little or no ocular irritation (Table 8). 92 In Vitro ...
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This is a safety assessment of Avena sativa (oat)–derived ingredients. The reported functions of these ingredients in cosmetics include abrasives, antioxidant, skin conditioning agents, absorbents, and bulking agents. The Panel reviewed relevant animal and human data related to these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may lead to sensitization or other toxic effects. The Panel stated that industry should continue to use good manufacturing practices to limit impurities and concluded that all but one of the Avena sativa (oat)–derived ingredients are safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment when formulated to be nonsensitizing; data are insufficient to come to a conclusion of safety for Avena Sativa (Oat) Meristem Cell Extract.
... It has been used since Roman times for cleansing the skin, and as a therapy for multiple dermatological conditions. Today, colloidal oatmeal is available in skin moisturizers, cleansers, shampoos and shaving products, among other products, which are used in some cases as adjunctive therapy in infants with moderate-to-severe atopic dermatitis [43]. ...
... The safety of cosmetics containing oatmeal for sensitive skin was ascertained. However, there are no studies evaluating the efficacy of these active ingredient specifically for this condition [43]. ...
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Objective Sensitive skin is characterized by self-reported sensory perceptions in response to stimuli that should not provoke unpleasant sensations. Cosmetic products for sensitive skin are designed to minimize these symptoms. This study aims to unveil the most used active ingredients for sensitive skin in facial care products. Methods A pool of products whose label included the expressions “sensitive skin”, “reactive skin” or “intolerant skin” were analyzed. The active ingredients were identified from product compositions and ranked in descending order of occurrence. The scientific evidence regarding the mechanism of action and efficacy of each ingredient was also compiled. Results Eighty-eight products from 19 multinational brands were included. Niacinamide leads the top, followed by Avena sativa, allantoin, glycyrrhetinic acid and derivatives and Laminaria ochroleuca. Ingredients which can reduce skin inflammation and act on the skin barrier were used in more than half of the products analyzed. The clinical studies regarding the active ingredients used in these products remain sparse and lack methodological quality. Among the top ingredients, niacinamide, panthenol and acetyl dipeptide-1 cetyl ester were the only ones studied on volunteers having sensitive skin, while acetyl dipeptide-1 cetyl ester and palmitoyl tripeptide-8 were designed to act on the molecular targets involved in this condition. Conclusion This study reveals the most used active ingredients in cosmetic products for sensitive skin, as well as the scientific evidence supporting their efficacy and the mechanisms of action. This insight is meaningful for dermatologists and other health professionals to provide customized advice based on the symptomatology of individuals with sensitive skin, and for the formulation of cosmetic products and design of new active ingredients.
... Skin hydration, appearance of squamae and skin roughness were significantly more improved than on the control area at all time points for those using the oatmeal product, including at 2 weeks after 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. ...
... 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 efficacy and tolerability of oatmeal moisturizer containing colloidal oatmeal and observed a significant reduction in the symptoms of patients. ...
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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.
... 34 The hand cream contained oat flour, which can be a skin sensitizer. However, reports on this allergen are rare 35 and none of the participants had to be excluded due to an allergy to this substance; the same applies for fragrances. Also, we did not observe any adverse skin reactions to the products provided. ...
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Background: Occupational hand eczema (HE) is common among healthcare workers (HCWs) and has - in some regions of the world - increased during the COVID-19 pandemic due to related hygiene measures. Objectives: To evaluate the efficacy of an intervention for HE prevention in HCWs during the pandemic. Methods: A prospective, controlled, unblinded interventional trial was conducted in 302 HCWs. The intervention group (IG) (n = 135) received online-based health education and free access to hand cleansing and hand care products. The control group (CG) (n = 167) did not receive any intervention within the study. At baseline (T0), after three (T1) and six (T2) months, participants completed standardised questionnaires. The Osnabrueck Hand Eczema Severity Index (OHSI) was assessed at T0 and T2. Results: During the observation period, there were no new HE cases in the IG (n = 115) and 12 cases (8.8%) in the CG (n = 136). OHSI values at T2 were lower in the IG (b = -1.44, P < 0.001). Daily use of emollients was higher at work (b = 1.73, P < 0.001) and at home (b = 1.62, P < 0.001) in the IG at T2. Conclusions: The intervention was effective in HE prevention and improving skin care behaviour during the COVID-19 pandemic. This article is protected by copyright. All rights reserved.
... 53 In similar findings, results of another study demonstrated that colloidal oatmeal is a safe ingredient in personal care products (creams, cleansers, lotions) and irritation and allergenic potential of the study materials were low. 54 Therefore, this margin of safety and excellent efficacy makes colloidal oatmeal as an attractive therapeutic option in the management of chronic HE. ...
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Background: Irritant contact dermatitis (ICD) is the most frequent cause of hand eczema (HE). There is promising evidence with the use of topical oatmeal compounds in the management of inflammation- and itch-responses associated with diverse dermatologic conditions. This study aimed to evaluate the clinical benefit of colloidal oatmeal cream in the management of chronic irritant HE. Methods: From October 2018 to November 2019, 79 patients with diagnosis of chronic irritant HE were allocated into either intervention or control groups by block randomization method. Besides fluocinolone 0.025% ointment for the first 2 weeks of treatment period, patients in the intervention and control groups were asked to use colloidal oatmeal 1% cream or base cream for additional 4 weeks as monotherapy. Changes in the HE severity based on the hand eczema severity index (HESCI) score, pruritus severity based on the visual analogue scale (VAS), and impact of skin disorder on patients quality of life based on the Dermatology Life Quality Index (DLQI) from baseline to weeks 2, 4, and 6 were assessed in the study groups. Results: Fifty subjects, 26 in intervention and 24 in control, completed the course of the study. The results indicated, though relatively comparable decrease in mean HESI and VAS scores was observed in both groups by the end of week 2, thereafter until end of the study a non-return of symptoms to baseline conditions was observed in the intervention group, while there was a significant return of symptoms to baseline conditions in the control group (p value<0.001 in both conditions). Further, a noticeable improvement in the DLQI score was seen in the intervention group compared with the control group (p value<0.001). Conclusion: Findings demonstrate that colloidal oatmeal, a natural product with proven barrier protection, moisturization, anti-inflammatory, and soothing properties, can have ameliorative effects on eczema severity symptoms in patients with chronic irritant HE.
... The historical record reports the use of oats (Avena sativa) to treat skin conditions thousands of years of years ago. Today, oats, in particular colloidal oats, are present in many commercial personal care products (e.g., soaps, shampoos, and shaving creams) (30,31). Identification of active molecules in oats identified avenanthramide alkaloids (32,33) which have antioxidant and anti-inflammatory activity in vitro (34) and in vivo (35). ...
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Fatty acid esters of hydroxy fatty acids (FAHFAs) are a recently discovered class of biologically active lipids. Here, we identify the linoleic acid ester of 13-hydroxy linoleic acid (13-LAHLA) as an anti-inflammatory lipid. An oat oil fraction and FAHFA-enriched extract from this fraction showed anti-inflammatory activity in LPS-induced cytokine secretion assay. Structural studies identified three LAHLA isomers (15-, 13-, and 9-LAHLA) as being the most abundant FAHFAs in the oat oil fraction. Of these LAHLAs, 13-LAHLA is the most abundant LAHLA isomer in human serum after ingestion of liposomes made of fractionated oat oil, and it is also the most abundant endogenous LAHLA in mouse and human adipose tissue. As a result, we chemically synthesized 13-LAHLA for biological assays. 13-LAHLA suppresses LPS-stimulated secretion of cytokines and expression of pro-inflammatory genes. These studies identify LAHLAs as an evolutionarily conserved lipid with anti-inflammatory activity in mammalian cells.
... In addition, it also showed sustained skin moisturizing properties in individuals with dry skin which lasted up to 2 weeks after product discontinuation. [12] A study by Reynertson et al. demonstrated the benefits of colloidal oatmeal skin protectant lotion in 29 healthy female controls with bilateral mild-to-moderate itching due to dry skin on their lower legs. After treatment, it was observed that the colloidal oatmeal extract reduced pro-inflammatory cytokines in vitro and remission in all the clinical signs such as skin dryness, scaling, roughness, and itch intensity. ...
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Background: Dry skin or xeroderma is a very frequent condition which occurs at any age. Moisturizers including conventional oatmeal have been widely used to improve dry skin conditions. Oat-based moisturizer can protect, hydrate, and promote the endogenous barrier repair. Aim: This study aims to evaluate the efficacy and safety of oat extract-based moisturizer in adult individuals with dry skin. Materials and Methods: This study was a treatment-randomized, assessor-blinded, no treatment controlled, comparative study. A total of 36 individuals were included in the study. Oat extract-based moisturizer (test product) and control treatment (no product application) were randomized, as per randomization plan and applied to all individuals on the surface of volar forearm 2 cm (1 cm radius) in diameter. In addition, right cheek as control site and left cheek as test site (oat extract-based moisturizer lotion) were considered for sebum level and facial skin pH analysis. Results: Oat extract-based moisturizer possessed excellent skin moisturizing properties. Both the Corneometer® and modified Kligman score, respectively, showed significant improvement (P < 0.0001) in skin hydration and decrease in skin dryness with respect to baseline till 24 h postapplication. Furthermore, Cutometer® reading had statistically significant increase in skin elasticity as compared to baseline till 6 h postapplication. There was no statistically significant effect on skin pH and sebum level as compared to control treatment. This concludes that oat extract-based moisturizer is effective in improving skin hydration and elasticity without any change in skin pH and sebum levels. Conclusion: Test product (oat extract-based moisturizer lotion) was safe and well tolerated. Efficacy analysis showed that the effect of oat extract-based moisturizer was significant in terms of skin hydration and skin elasticity.
... during the period (days 1-28) of oatmeal-containing cream application and afterwards (day 42) compared with baseline. In addition it has been stated that oatmeal-containing personal care products have a very low irritantion potential as well as a very low allergen sensitization potential-low-level reactions were documented only in 1.0% of subjects [23]. According to Ayurvedic literature, linseed is believed to control aging processes, improve wound healing and improve the moisture holding capacity of the skin [24]. ...
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The increased interest in natural cosmetics has resulted in a higher market demand for preservative-free products based on herbal ingredients. An innovative W/O/W type emulsions containing herbal extracts were prepared directly; its cation form was induced by an ethanolic rosemary extract and stabilized using weak herbal gels. Due to the wide phytochemical composition of herbal extracts and the presence of alcohol in the emulsion system, which can cause skin irritation, sensitization or dryness when applied topically, the safety of the investigated drug delivery system is necessary. The aim of our study was to estimate the potential of W/O/W emulsions based on natural ingredients for skin irritation and phototoxicity using reconstructed 3D epidermis models in vitro and to evaluate in vivo its effect on human skin moisture, sebum content and pigmentation by biomedical examination using a dermatoscopic camera and corneometer. According to the results obtained after in vitro cell viability test the investigated emulsion was neither irritant nor phototoxic to human skin keratinocytes. W/O/W emulsion did not cause skin dryness in vivo, despite the fact that it contained ethanol. We can conclude that the emulsion is safe for use as a leave-on product due to the positive effect on human skin characteristics or as a semisolid pharmaceutical base where active compounds could be encapsulated.
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White Birch Sap (WBS) contains appreciable amounts of mineral ions and phenolic compounds and can be used as alternate solvent for food applications. In this study, the effect of the mineral and phenolic composition of WBS was evaluated on the physical properties of xanthan gum, guar gum, ultra-finely milled oatmeal and their combinations in solution. Solutions were formulated with WBS and with solvents mimicking WBS without phenolic compounds and WBS without phenolics nor mineral ions. The influence of solvent composition was evaluated on flow properties and water mobility of the solutions. From WBS without mineral ions nor phenolics, the addition of mineral ions led to increased pseudo-plasticity and decreased flow consistency, and decreased water mobility. Addition of phenolic compounds through WBS led to opposite effects possibly due to phenolic-driven aggregation of the hydrocolloids which also seemed to inhibit guar/xanthan interactions.
Chapter
Oat represents an important agricultural resource whose potential use in the bakery industry is insufficiently exploited. The investigation of this potential starts from the transformation of oat kernel into flour and ends with obtaining the wheat-oat mixtures bakery products. Oat flour contains no gluten but provides significant amounts of lipids and fibers with important nutritional value. β-Glucans from oat lower blood cholesterol and decrease blood glucose level. The lack of gluten and the fibers intake limit the oat flour potential for use in bakery, the products obtained exclusively from oat, being characterized by an unacceptable volume and texture. However, using conventional technologies and addition of whole oat flour up to 30% to wheat flour (WF), bakery products with good sensory characteristics accepted by consumers can be obtained. These products are characterized by a higher nutritional profile than those obtained exclusively from WF and contribute to the diversification of Western diets.
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There is a growing awareness that some individuals exhibit heightened skin sensitivity, particularly on the face, and have a high incidence of adverse reactions to cosmetics and toiletries. To carry out an epidemiological study to assess the prevalence of sensitive skin and cosmetic-related adverse events in a U.K. population, and to examine possible factors that may be associated with sensitive skin. Self-assessment questionnaires were sent out to 3300 women and 500 men, randomly selected, who were over the age of 18 years and lived within a 10-mile radius of High Wycombe (Bucks.). Fifty non-responder women were also questioned by telephone to ensure that the postal responders were representative of the population as a whole. The response rates were 62% for women and 52% for men, with the incidence of self-reported skin sensitivity being 51.4% and 38.2%, respectively. Ten per cent of women and 5.8% of men described themselves as having very sensitive skin. Fifty-seven per cent of women and 31.4% of men had experienced an adverse reaction to a personal product at some stage in their lives, with 23% of women and 13.8% of men having had a problem in the last 12 months. Among the women, symptoms of cosmetic-induced subjective sensory skin discomfort (burning, stinging, itching etc.) occurred more commonly in the sensitive skin cohort (53%) than in those who regarded themselves as non-sensitive (17%). An atopic diathesis in women did not appear to be a predictive factor for sensitive skin, the incidence of self-perceived sensitive skin being equivalent for atopics (49%) and non-atopics (51%). Furthermore, some 34% of atopic women described themselves as being non-sensitive. Nevertheless, the incidence of atopy was higher among the women in the sensitive skin group (49%) than among those in the non-sensitive group (27%). Dry skin and a predilection for blushing/flushing were associated factors for sensitive skin. Our survey indicates that sensitive facial skin is a common problem for women and men in the U.K. and points to the need for the development of personal products designed for this skin phenotype.
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To examine possible ethnic variations in perception of sensitive skin, an epidemiological survey was performed in the San Francisco area. Approximately 800 telephone interviews were conducted with women from four different ethnic groups (Afro-Americans, Asians, Euro-Americans, Hispanics; approximately 200 women per group). In addition to sensitive facial skin assessments, age and other general skin condition data were collected. 52% of the subjects identified themselves as having sensitive facial skin. There was no statistical difference between the ethnic groups in terms of sensitive skin prevalence. Nevertheless, some differences were noted between ethnic subgroups of sensitive skin. Euro-Americans were characterized by a higher skin reactivity to wind and tended to be less reactive to cosmetics. Afro-Americans presented diminished skin reactivity to most environmental factors and a lower frequency of recurring facial redness. Asians appeared to have greater skin reactivity to spicy food, to sudden changes in temperature and to wind, and tended to suffer from itching more frequently. Hispanics presented a lower incidence of skin reactivity to alcohol. The differences in skin sensitivity between ethnic groups concerned mostly factors of skin reactivity and, to a lesser extent, its symptomatology. But, taken together, we note the similarities in comparing how women of varying ethnic backgrounds perceive the sensitive skin condition.
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Atopic dermatitis, one of the most common skin disorders in young children, has a prevalence of 10% to 20% in the first decade of life. It is a chronic illness that requires a multifaceted treatment strategy in the setting of limited therapeutic options. Balancing safety concerns with efficacious treatment is of particular importance in the pediatric population. Parents of patients with atopic dermatitis turn to their primary caregivers for guidance regarding this physically demanding and psychologically stressful condition. In addition to serving as a review of atopic dermatitis, this article delves into the state-of-the-art therapeutic options and includes a detailed review of the differences between topical corticosteroids and topical calcineurin inhibitors. We also discuss new treatment strategies that are being used by atopic dermatitis specialists, such as comprehensive "education-as-intervention" models, wet wraps, bleach baths, and systemic immunomodulatory therapies.
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Atopic dermatitis is a common multifactorial disease that seems to be increasing in frequency. Our purpose was to determine the increased prevalence of atopic dermatitis in North Europe. Approximately 3000 7-year-old children in Denmark, Germany, and Sweden were enrolled in a cross-sectional questionnaire study that was conducted in the autumn of 1992 with common protocols and standardized procedures. The response rate was 90%. The frequency of atopic dermatitis was calculated to be 15.6% (95% confidence interval 14.2% to 17%) with some regional differences. Girls more often had flexural eczema and outnumbered boys in a ratio of 1.3:1.0. Boys more often had a personal history of asthma, whereas girls more often had a family history of asthma. The increasing prevalence of atopic dermatitis has been confirmed. This simple questionnaire model works well, is cost effective, and is sufficiently sensitive and specific to conduct large-scale epidemiologic investigations in school children.
Colloidal grain suspensions have been used for decades as adjuncts in the treatment of atopic dermatitis, especially in the US. In Italy, many young children have been exposed to colloidal grains. Recently, it was suggested that these bath therapies may induce allergic contact dermatitis in some young atopic children. To evaluate the allergic skin reactions to topical oat and rice colloidal grain suspensions of normal and atopic children with and without previous exposure to colloidal grain suspensions. A double-blind, randomized patch study. Two concentrations of oat and rice colloidal grains (0.007% and 0.7%) were applied occlusively to the backs of 65 children living in Italy, ages 6 months to 2 years (43 were atopic and 22 were normal). There were neither immediate urticarial nor allergic reactions in any of the 65 study subjects, atopic or nonatopic; 5 of 43 (12%) atopic subjects developed irritant reactions to the test materials. Radioallergosorbent tests (RAST) tests were performed on 55 subjects. The negative RAST test results found in the nonatopic group correlated well with nonatopic status, but positive RAST tests were found in only 8 of 35 (23%) atopic dermatitis subjects. None of the sera from positive RAST scores corresponded to subjects with irritant patch reactions. The data indicate that topical colloidal grains can be used as an adjunct in the management of mild atopic dermatitis in children under 2 years of age. There was no evidence of sensitization to topical colloidal grains in the group studied.
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Atopic dermatitis (AD), one of the most common skin disorders seen in infants and children, usually has its onset during the first 6 months of life. The prevalence of AD is similar in the United States, Europe, and Japan and is increasing, similar to that of other atopic disorders, particularly asthma. AD has been classified into 3 sequential phases: infantile, childhood, and adult, each with characteristic physical findings. AD has a tremendously negative effect on the quality of life of patients as well as family, most commonly disturbing sleep. The condition also creates a great financial burden for both the family and society. The cutaneous manifestations of atopy often represent the beginning of the atopic march. On the basis of several longitudinal studies, approximately half of AD patients will develop asthma, particularly with severe AD, and two thirds will develop allergic rhinitis. Epicutaneous sensitization has been thought to be responsible, with subsequent migration of sensitized T cells into the nose and airways, causing upper and lower airway disease. Animal models and human observation concur with this theory. Preliminary prevention studies with oral antihistamines provide evidence that early intervention might slow the atopic march.