Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 263-270
Published Online December 2013 (http://www.scirp.org/journal/jcdsa)
http://dx.doi.org/10.4236/jcdsa.2013.34040
Open Access JCDSA
263
Evaluation of a Barrier Repair Cream Containing
Pseudo-Ceramide for Practical Use by Hairdressers with
Hand Skin Disorders Due to Daily Exposure to Chemical
Irritants
Akihiko Takahashi1*, Annette Kirst2, Ulrike Heinrich3, Akira Kiyomine2, Koichi Ishida1,
Hagen Tronnier3, Heintz Theis2, Takahiro Nishizaka1, Hisateru Tanabe1
1Kao Corporation, Skin Beauty Laboratories, Tokyo, Japan; 2Kao Germany, European Research Laboratories, Darmstadt, Germany;
3Derma Tronnier, University of Witten-Herdecke, Witten, Germany.
Email: *takahashi.akihiko@kao.co.jp
Received October 24th, 2013; revised November 20th, 2013; accepted November 28th, 2013
Copyright © 2013 Akihiko Takahashi et al. This is an open access article distributed under the Creative Commons Attribution Li-
cense, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Hairdressers are exposed to numerous skin-damaging factors, such as wet work, skin irritants, and thermal changes.
Skin protection is a very important factor for the prevention of occupational skin disorders. Therefore, we evaluated a
hand cream that was specially formulated for highly stressed skin with rega rd to its capability to reduce dry, rough, and
scaly skin. The objective of this study was to conduct a controlled use test of a barrier repair cream containing
pseudo-ceramide and demonstrate its efficacy for hairdressers with dry, sensitive hands and/or occupational skin disor-
ders. A total of 30 hairdressers (29 females and 1 male, aged 20 - 67) participated in the study. All subjects suffered
from dry hands. Subjects applied th e test cream on their hands for 28 days (four weeks). For each subject, the skin sur-
face topography of the hands was measured by the Surface Evaluation of Living Skin (SELS) system at day 14 (week 2)
and day 28 (week 4). Dryness, scaling, cracking, redness, and itchiness were evaluated and graded by experts at week 2
and week 4, and then compared to baselines. All 30 subjects completed the study. A comparison of the changes from
baseline to endpoint revealed a statistically significant reduction in skin roughness, scaling, and volume measured ac-
cording to SELS. These data were confirmed by photographic documentation. The results were further supported by the
expert evaluation. For the symptoms dryness and scaling, improvement could be observed in almost all regions of the
hands. In addition, according to subjective assessments of overall hand skin condition and the hand cream, subjects re-
ported clear improv ement over time (p value below 0.001) and good eff icacy of the product. In th is study, the test hand
cream showed excellent skin compatibility. Therefore, the hand cream may be effective for hairdressers with dry, sensi-
tive hands and/or occupational skin disorders.
Keywords: Occupational Skin Disorder; Hairdresser; Der m at ol ogi cal Cont r ol l ed Use Te st ; Pseudo -C eramide; Barri er
Cream; Topical Hand Care
1. Introduction
It is well known that excessive cleansing with detergents
is one of the causes of skin dryness and roughness.
Consequently, many hairdressers who are exposed to
chemical irritants, such as those contained in shampoos
and hair dyes, on a daily basis suffer from occupational
skin disorders [1,2]. Exogenous occupational irritants
that deteriorate the skin barrier are considered one of the
causes of occupational skin disorders. It is known that
stratum cornium intercellular lipids, especially cera mides,
play an important role in the maintenance of the skin
barrier [3-6], but stratum cornium intercellular lipids are
washed away by surfactants [7]. As a result, they lower
the skin barrier, leading to skin disorders.
For this reason, barrier cream containing ceramide has
been developed in recent years, and its efficacy in occu-
pational sk in disor d ers has bee n e va l u ated [8] .
Although some researchers have reported on the effi-
*Corresponding author.
Evaluation of a Barrier Repair Cream Containing Pseudo-Ceramide for Practical Use by Hairdressers
with Hand Skin Disorders Due to Daily Exposure to Chemical Irritants
264
cacy of ceramide barrier cream in dry, scaly skin induced
artificially by detergents [9,10], no clinical studies have
been conducted on a barrier cream containing ceramide
for hairdressers who are exposed to chemicals on a daily
basis. Therefore, improvement of hand skin symptoms in
hairdressers has not been clinically observed.
We developed a skin barrier cream containing synthe-
sized pseudo-ceramide and allantoin, and carried out a
controlled use test in hairdressers who had symptoms of
dry, sensitive sk in on their hands.
2. Materials and Methods
2.1. Test Product
A test hand cream formulation, containing pseudo-cera-
mide (Figure 1) and allantoin, was prepared for this
study. INCI declaration: Water (Aqua), Cyclopentasi-
loxane, Glycerin, Cetyl-PG Hydroxyethyl Palmitamide
(Pseudo-ceramide), Hydrogenated Polyisobutene, Neo-
pentyl Glycol Ether, Cetyl Dimethicone, Cholesteryl Iso-
stearate, Eucalyptus Globulus Leaf Extract, Magnesium
Sulfate, Allantoin, Methylparaben, Succinic Acid, PEG-
10 Hydrogenated Castor Oil, Sodium Hydroxide, Toco-
pheryl Acetate, Bis-Methoxypropylamide Isodocosane.
Pseudo-ceramide was synthesized following the proce-
dures in a previous report [11].
2.2. Selection of Test Subjects
Thirty healthy hairdr essers (29 females and 1 male) aged
between 20 and 67 years of age (40.5 ± 12.6 years) who
suffered from dry, sensitive skin on th eir hands and were
able to visit the University of Witten-Herdecke in Ger-
many were selected as test subjects for the study (Table
1).
2.3. Study Design
This was a monadic study without any control group.
After a three-day regression period (during which sub-
jects were not allowed to use hand care products on their
hands), the test subjects applied the test product on their
hands, instead of their own hand cream products, at least
three times per day over a period of four weeks (28 days).
Expert evaluation, instrument measurement, digital pho-
tography, and a questionnaire were performed on day 0
(baseline), day 14 (week 2), and day 28 (week 4). The
study was realized from April to Ma y 2012.
Figure 1. Chemical structure of pseudo-ceramide (Cetyl-PG
Hydroxyethyl Palmitamide).
2.4. Skin Physiological Parameters
The skin surface topography was measured with the Vi-
sioscan® VC98 (Courage & Khazaka Electronics GmbH,
Germany). All subjects were required to undergo a thirty-
minute acclimation period (22˚C, 40% relative humidity).
The values recorded were means of three measurements.
The Surface Evaluation of Living Skin (SELS) [12]
measuring device consists of a measuring head (Visio-
Scan C, Courage & Khazaka, Cologne) containing two
special metal-halogenide lights arranged on opposite
sides that uniformly illuminate a 15 × 17 mm measuring
area of the skin. The spectrum of the lamps as well as
their intensity and location had been chosen in such a
way that only the skin surface, without reflections of
deeper layers, was monitored. Furthermore, unlike with
formerly applied procedures with diagonal illumination,
with SELS, a distinct representation of the wrinkling is
avoided. A CCD-camera, built into the measuring head,
takes an image of the sk in, which is then transferred as a
gray-value bitmap-file by means of the software Skinvi-
siometer (Courage & Khazaka, Cologne). The color
value for each pixel corresponds to quantification with
eight bits, which allows a differentiation into 256 grey
values. The value “0” corresponds to the color “black”,
and the value “255” corresponds to the color “white”. By
means of the additional software, the SELS skin specific
parameters (roughness, scaling, wrinkles, and volume)
are then calculated.
2.5. Expert Evaluation
To determine skin dryness, scaling, cracking, redness,
and itchiness of the hands, a subjective visual evaluation
of each test subject was conducted by an expert accord-
ing to the following four grade scales: 0 = none, 1 =
slight symptoms, 2 = mild symptoms, and 3 = moderate
symptoms. Dryness, scaling, cracking, redness, and
itchiness were recorded for the palm side (palm, fingers,
fingertips) and back side (back, fingers, fingertips).
2.6. Subjective Evaluation
For the subjective assessment of the test product, cos-
metic acceptance and satisfaction of hand skin condition
were evaluated. The subjects assessed the cosmetic ac-
ceptance and rated the product as “very bad”, “bad”,
“neither good nor bad”, “good”, or “very good”. The
subjects’ satisfaction with their hand skin condition at
baseline, week 2, and week 4 were rated as “not satis-
fied”, “not so satisfied”, “somewhat satisfied”, “satis-
fied”, and “extremely satisfied”.
2.7. Digital Photography
T
o objectively measure the responsiveness to the treat-
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with Hand Skin Disorders Due to Daily Exposure to Chemical Irritants
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265
Table 1. Hand skin condition at baseline visit.
Front side Back side
Symptom Grading Hand Finger Finger tip Hand Finger Finger tip
None:0 15 13 14 0 0 3
Slight:1 8 7 9 6 7 4
Mild:2 4 7 5 14 15 17
Moderate:3 3 3 2 10 8 6
Dryness
Average 0.83 1 0.83 2.13 2.03 1.87
None:0 24 20 24 11 12 16
Slight:1 3 8 3 9 12 9
Mild:2 1 71 2 7 6 1
Moderate:3 2 1 1 3 0 4
Scaling
Average 0.37 0.43 0.33 1.07 0.8 0.77
None:0 30 30 27 26 28 25
Slight:1 0 0 2 2 0 2
Mild:2 0 0 0 1 2 2
Moderate:3 0 0 1 1 0 1
Cracking
Average 0 0 0.17 0.23 0.13 0.3
None:0 30 30 30 12 17 27
Slight:1 0 0 0 10 8 2
Mild:2 0 0 0 7 5 1
Moderate:3 0 0 0 1 0 0
Redness
Average 0 0 0 0.9 0.6 0.13
None:0 26 28 29 13 16 26
Slight:1 4 1 0 7 9 2
Mild:2 0 1 1 8 5 2
Moderate:3 0 0 0 2 0 0
Itchiness
Average 0.13 0.1 0.07 0.97 0.63 0.2
ment of the highly stressed skin on the hands, photo-
graphic documentation was performed (Fotofinder Sys-
tems GmbH, Bad Birnbach, Bavaria, Germany).
2.8. Ethics
The study protocol was approved by the ethical commit-
tee of the University of Witten-Herdecke. All participat-
ing test subjects were informed about the objectives and
scope of the study and provided written informed consent
prior to the study. The study was carried out in accor-
dance with the GCP-Guideline.
2.9. Statistical Analysis
A two-sided Wilcoxon signed rank sum test was used for
statistical analysis of the SELS and questionnaire data.
The statistical analysis of the visual evaluation by ex-
perts was performed by Steel’s multiple comparison test
to investigate differences in distributions in comparison
to baselines.
P-values of less than 0.05 were cons idered as statistic-
cally significant.
First, confirm that you have the correct template for
your paper size. This template has been tailored for out-
Evaluation of a Barrier Repair Cream Containing Pseudo-Ceramide for Practical Use by Hairdressers
with Hand Skin Disorders Due to Daily Exposure to Chemical Irritants
266
put on the custom paper size (21 cm * 28.5 cm).
3. Results
All thirty enrolled test subjects completed the study. All
participants had used their own hand care products on
their hands prior to the study, and had dry hand skin at
the baseline visit.
The SELS parameters roughness, scaling, wrinkles,
and skin volume were evaluated. Skin roughness pa-
rameter decreased by 29.7% (p = 0.0002) after two
weeks and by 32.1% (P = 0.0003) after four weeks of
treatment with the test product compared to baseline
(Figure 2). Scaling parameter decreased by 51.4% (p <
0.0001) after two weeks and by 49.7% (p < 0.0001) after
four weeks of treatment with the test product compared
to baseline (Figure 3). Skin wrinkle parameter decreased
Figure 2. Skin roughness: At baseline and after 2 and 4
weeks of hand cream treatment the skin roughness was
assessed. Statistical differences in skin roughness between
baseline and after 2 weeks’ and 4 weeks’ treatment are in-
dicated (*p < 0.05, **p < 0.01, ***p < 0.001 Wilcoxon signed-
rank test). The bars indicate SD of means for 30 test sub-
jects.
Figure 3. Skin scaling: At baseline and after 2 and 4 weeks
of hand cream treatment skin scaling was assessed. Statis-
tical differences in skin scaling betw een baseline and after 2
weeks’ and 4 weeks’ treatment are indicated (*p < 0.05, **p
< 0.01, ***p < 0.001 Wilcoxon signed-rank test). The bars
indicate SD of means for 30 test subjects.
by about 3% after two weeks and after 4 weeks of treat-
ment with the test product. Thus , there were no statistical
significances between skin wrinkles after two weeks (p =
0.217) and four weeks (p = 0.109) compared to baseline
(Figure 4). The parameter volume is the virtual amount
of liquid which is required to fill the depth. Thus, the
smoother the skin, the less virtual liquid is needed to fill
the depth. The skin volume significantly decreased by
16.1% (p = 0.002) after two weeks and by 15.75% (p =
0.0239) after four weeks of supplementation (Figure 5).
In addition to the SELS analysis, improvements of the
skin were assessed by comparing observations of the
dryness, scaling, cracking, redness, and itchiness of the
skin by experts at different time intervals.
At baseline, all subjects had skin dryness on the backs
of their hands and fingers. Severities of dryness, scaling,
cracking, redness, and itchiness on the backs of their
hands were worse than those of the palms. The mean
Figure 4. Skin wrinkles: At baseline and after 2 and 4 weeks
of hand cream treatment skin wrinkles were assessed.
Statistical differences in skin wrinkles be tween baseline and
after 2 weeks’ and 4 weeks’ treatment are indicated (*p <
0.05, **p < 0.01, ***p < 0.001 Wilcoxon signed-rank test). The
bars indicate SD of means for 30 test subjects.
Figure 5. Skin volume: At base line and after 2 and 4 weeks
of hand cream treatment skin volume was assessed.
Statistical differences in skin volume between baseline and
after 2 weeks’ and 4 weeks’ treatment are indicated (*p <
0.05, **p < 0.01, ***p < 0.001 Wilcoxon signed-rank test). The
bars indicate SD of means for 30 test subjects.
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with Hand Skin Disorders Due to Daily Exposure to Chemical Irritants
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267
grade of dryness on the backs of hands went from 2.13 at
baseline down to 1.00 at week 2, and then further down
to 0.20 at week 4. Along with the improvement of hand
skin dryness, the mean grades of scaling, redness, and
itchiness also decreased (Figure 6).
No side effects (adverse reactions) were observed
Figure 6. Expert gradings: At baseline and after 2 and 4 weeks of hand cream treatment, experts graded 6 regions of the
hands. Statistical differences in expert gradings between baseline and after 2 weeks’ and 4 weeks’ treatment are indicated (*p
0.05 Steel’s multiple comparison test). <
Evaluation of a Barrier Repair Cream Containing Pseudo-Ceramide for Practical Use by Hairdressers
with Hand Skin Disorders Due to Daily Exposure to Chemical Irritants
268
throughout the study period for all test subjects. In
regards to skin compatibility of the test product, 70.0%
[21] of the test subjects were very satisfied and 30.0% [9]
were satisfied. Therefore, all test subjects were pleased
with skin compatibility, indicating that the test product
was very good in terms of skin compatibility ( Table 2).
According to subjective assessments of overall hand
skin condition, subjects reported improvement through-
out the test period (Figure 7). In terms of cosmetic ac-
ceptance, 93.3% of test subjects rated the test product as
“very good” or “good” at week 4 (Table 3).
The positive effects on th e skin of the hands shown by
skin physiological parameters measured by the SELS
method and by expert evaluation, as well as the noted
subjective assessments, were confirmed by digital pho-
tographic documentation. A selection of representative
digital photographs is shown in Figure 8. Before the
Figure 7. Changes in subjective assessment of satisfaction of
hand skin condition: After daily applications of test hand
cream, subjects’ satisfaction of their hand skin condition
improved significantly (Week 2 versus Baseline: p < 0.001,
Week 4 versus Baseline: p < 0.001 Wilcoxon signed-rank
test).
Table 2. Skin compatibility.
Number %
Very good 21 70
Good 9 30
Fair 0
0
Satisfactory 0 0
Unsatisfactory 0 0
Insufficient 0 0
Table 3. Subjects’ assessment of the clinical acceptance of
the test hand cream.
N % Cumulative %
Very good 13 43.3 43.3
Good 15 50 93.3
Neither goog nor bad 2 6.7 100
Bad 0 0 100
Very bad 0 0 100
Case 1 Baseline Week 2 Week 4
Case 2 Baseline Week 2 Week 4
Figure 8. Photographic documentation: At baseline visit,
the skin was rough, flaky, and dry. However, after daily
applications of the test hand cream, the skin on the hands
appeared shiny, smooth, and well maintained.
treatment, the skin was rough and dry. However, after
daily application of the test product for four weeks, the
skin on the hands appeared shiny, smooth, and well
maintained.
4. Discussion
Hairdressers are exposed to numerous skin-damaging
facto rs, such as wet work , chemical irritants, and thermal
changes. In f act, 87 % of the subj ects of this stu dy did n ot
wear gloves while shampooing hair, and 77% of them
did not wear gloves while perming hair (Table 4). Thus,
skin protection by hand care treatment is a very im-
portant factor for the prevention of occupational skin
disorders.
Ceramide is well known as one of the stratum cornium
intercellular lipids that play an important role in the
maintenance of sk in barrier function [3]. With a decrease
in the amount of ceramide and other stratum cornium
intercellular lipids, the skin barrier function lowers on
atopic dermatitis [4]. Decreased ceramide level is caused
by an abnormality in ceramide metabolism in atopic
dermatitis [13,14]. It has been reported that application
of barrier repair cream containing ceramide improves
atopic symptoms along with improvement of the skin
barrier function as measured by transepidermal water
loss [15,16].
However, detergents are known to cause dry skin
problems since they facilitate the flowing out of stratum
cornium intercellular lipids [7]. Previous reports have
shown the efficacy of treatment with topical creams
containing ceramide in cases of dry skin induced by
detergents [8,9], but there have been no reports on the
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Evaluation of a Barrier Repair Cream Containing Pseudo-Ceramide for Practical Use by Hairdressers
with Hand Skin Disorders Due to Daily Exposure to Chemical Irritants 269
Table 4. Glove use ratio of daily duties.
N (%)
Duty Hair shampoo Hair coloring Bleaching Hair perm (acid) Hair perm (alkali)
with globe 4 (13.3) 27 (90.0) 22 (73.3) 7 (23.3) 7 (23.3)
without globe 26 (86.7) 3 (10.0) 8 (26.7) 23 (76.7) 23 (767.7)
clinical efficacy of ceramide cream in occupational skin
disorders of hairdressers who are exposed to chemical
irritants on a daily basis. Therefore, a hand cream that
contains pseudo-ceramide and is formulated for highly
stressed skin of the hands is evaluated with regard to its
capability of reducing dry, rough, an d scaly skin.
A comparison of changes from baseline to endpoint
revealed a statistically significant reduction in skin
roughness, scaling, and volume measured according to
SELS. These data were confirmed by photographic
documentation.
The results were further supported by expert evalua-
tion. For the symptoms dryness and scaling, improve-
ments could be observed in almost all regions of the
hands.
In addition, self-assessment showed that overall hand
skin condition clearly improved over time (p value b elow
0.001), and test subjects reported good efficacy of the
test product.
Since problem skin requires special skin care, skin
care products have to be mild with excellent skin com-
patibility, preventing skin irritations and dryness. In this
study, the test hand cream showed excellent skin com-
patibility.
Since this study was a single-test without any controls,
we could not definitively declare the efficacy of the test
hand cream. However, though all of the subjects contin-
ued their daily work tasks, including shampooing and
perming hair, throughout the test period and had used
commercial hand care products until the study started,
the clinical scores and SELS measurements improved
significantly. In addition, by self-assessment, subjects
reported improved hand skin condition throughout the
test period. These results suggest that the test hand cream
is effective for dry hand skin problems in hairdressers.
In order to confirm the efficacy for occupational hand
skin eczema, we should conduct a double-blind study
using placebo as a control and measure skin barrier func-
tion to clearly demonstrate that the effects of the test
product are due to pseudo-ceramide and its ability to
maintain skin barrier function.
5. Acknowledgements
The authors would like to thank Mrs. Dipl. Stat. C.
Theek for her assistance, including statistical consulting
and evaluation of the data, and all the hairdresser sub-
jects, whose cooperation made this investigation possi-
ble.
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