DERMATOLOGIC ASPECTS OF COSMETICS
OO
MODERN SKIN CLEANSERS
Cleansing is an important part of everyday
life throughout the animal kingdom. For most
species, cleansing serves the purely functional
role of removing dirt and other unwanted
substances from the body’s surface. Among
humans, cleansing has frequently taken on
significance beyond the simple act of dirt re-
moval. For example, cleansing, or the prohibi-
tion thereof, has been an integral part of reli-
gious ceremony and belief throughout human
history. More recently, the act of cleansing has
been promoted as a means of relaxation and
escape from the cares of everyday life and
as a way to improve the skin’s health and
appearan~e.~, 12, *O, 44 Manufacturers have pro-
vided consumers with a dizzying array of
product choices composed of different colors,
scents, and a variety of ingredients purported
to provide skin benefits. New product forms
have been introduced, and although cleans-
ing bars still predominate, the growing popu-
larity of liquid soaps and body washes signals
an important change in the skin cleanser mar-
ket.
HISTORICAL PERSPECTIVE
In earliest times, cleansing likely was ac-
complished by using an implement of bone
or stone to scrape the skin. Later civilizations
used materials of plant origin with water for
From Clinical Research and Biometrics, Sharon Woods Technical Center, The Procter and Gamble Company, Cincin-
nati, Ohio
DERMATOLOGIC CLINICS
- -
VOLUME 18 NUMBER 4 OCTOBER 2000
0733-8635/00 $15.00 + .
Keith Ertel, PhD
cleansing. For example, the Hittites of Asia
Minor used a suspension of soapwort plant
ash to cleanse their hands.” Some peoples
continue to use plant materials for cleansing
today.
The discovery of the chemical entity known
as soap has been attributed to many different
civilizations. Some of the earliest accounts of
the soap-making process can be found in
Sumerian clay tablets dating to circa 2000
B.C.45, 70 The Babylonian and Egyptian cultures
practiced soap making in roughly the same
time frame.” The Phoenicians used tree ash
and animal fat to prepare soap circa 600
B.c.~‘,70 Roman legend holds that soap was
discovered near Mount Sapo, a site of burnt
animal sacrifices located outside Rome.24,45,
70* 75 The fat from these sacrifices combined
with wood ash as it was washed down the
mountainside by rainwater, forming soap.
Roman housewives discovered that the re-
sulting material was a useful aid for clothes
washing. The Romans did not use soap as an
aid to personal washing but did use it as a
hair dressing.70
Soap making continued to develop as an
art and fell under the guild system in Europe
during the Middle Ages. Soap use was not
widespread throughout much of the world
during this period because of religion and
economics. The Christian Church believed
that exposing the flesh, even for cleansing,
561
562 ERTEL
was evil and banned the use of soap.” Soap
also was taxed heavily in many European
countries, making it a luxury item rather than
a product to be used by the masses. This
practice of levying a tax on soap remained in
effect in some areas of Europe well into the
nineteenth century.45,70, 75
Two events were key to shaping the mod-
ern skin cleanser industry. The first was
Leblanc’s discovery of a process for con-
verting common salt into soda ash, a key
raw material in the soap-making process. The
availability of cheap raw materials for soap
manufacturing sparked the growth of the
soap-making industry and helped transform
soap from a luxury to a commodity item. The
second key event was the development of
synthetic detergents during World War 11,
driven by shortages of the natural fats and
oils needed to make soap and by the mili-
tary’s need for cleansing bars that performed
well under a variety of usage condition^.^^,^^
Many modern skin-cleansing products are
based on synthetic detergent systems.
CLEANSER COMPOSITION
Despite the many and varied forms skin
cleansers can take, they are often referred to
generically as soup. Soap, in a strictly chemical
sense, is the alkali salt of a fatty acid, most
commonly the sodium or potassium salt.
Most modern skin-cleansing products are
much more complex than the name soup im-
plies, containing not only surfactants, but also
skin-conditioning agents and a variety of
other ingredients to add color and scent, to
improve stability, to aid in processing and
manufacturing, or to modify the product’s in-
use performance.
Surfactants
Surfactants make up the bulk of most skin
cleanser formulas and are key determinants
of a product’s in-use properties. Surfactants
are responsible for many of a cleanser’s skin
effects. A surfactant, or surface-active agent,
is a material that moves to an interface when
it is dissolved in water. This can be the inter-
face between the surfactant solution and skin
or between the surfactant solution and air.
Surfactants act by lowering the interfacial ten-
sion at this interface. Put more simply, a sur-
factant increases the affinity of dissimilar
phases for each other. Surfactant molecules’
ability to lower interfacial tension is due to
their unique structure, which consists of a
polar, hydrophilic end and a nonpolar, hy-
drophobic end. Surfactants’ ability to localize
at interfaces and lower interfacial tension is
responsible for the properties normally asso-
ciated with skin cleansers, such as their abil-
ity to remove dirt and oils from the skin and
to form lather. Many modern skin-cleansing
products contain a mixture of different surfac-
tants, composed of a primary surfactant,
which determines the product’s overall char-
acteristics, and secondary surfactants, which
may be added, for example, to improve skin
compatibility or lather characteristics.
Soap
Soap is the prototypic surfactant used in
skin cleansers and continues to play a promi-
nent role in the personal cleansing market.
Soap bars are inexpensive and generally pro-
vide excellent cleaning and lather. Washing
with soap has been recommended as a useful
adjunct in the therapy of some skin diseasejm
although soap more frequently is recognized
for its potential to irritate skin. Soap and its
effects have been studied extensively, and a
discussion of its properties provides a good
basis for illustrating how cleansers can affect
the skin and for highlighting some of the
benefits synthetic surfactant-based products
may offer over traditional soaps.
As defined previously, soap is the alkali
salt of a fatty acid. Traditional soap making
was often a batch process in which fat was
heated with caustic to form soap. In contrast,
modern soap making is usually a continuous
process carried out by one of three routes:
saponification of triglycerides, which is akin
to the traditional soap-making process; neu-
tralization of fatty acids; or saponification of
75 The resulting
fatty acid methyl esters.21,24,45,
soap is then washed, dried, and finished.
The fatty acids used in modern soap manu-
facture are derived from animal (e.g., beef
 MODERN SKIN CLEANSERS 563

tallow) and natural ( e g , palm oil) sources,
and the ratio of animal-derived and plant-
derived soap present can affect the skin com-
patibility of the finished p r ~ d u c t The
. ~ fatty logue. Adsorption to skin was implicated as
acid starting material from both sources usu-
ally comprises a range of chain lengths, com-
monly from c8 to Cu, with saturated and
unsaturated fatty acid species present.
The properties of a finished soap product
are determined in large part by the composi-
tion of the fatty acid starting material. For
example, lather is a characteristic that many
consumers find aesthetically pleasing and of-
ten is viewed as an indicator of a skin cleans-
er’s ability to clean. Foaming or lathering
should be favored by increasing the chain
length of the hydrophobic portion of the sur-
tionship between alkyl sulfate chain length
and surfactant adsorption to callus in vitro,
with maximal adsorption for the C,, homo-
a causative factor for surfactants’ skin rough-
ening and tightening effect^.^^-^^
The coincidence of the chain-length distri-
bution maxima of soap’s desirable and unde-
sirable properties has been a limiting factor
to improving soap’s skin compatibility. One
approach to minimize the potential negative
skin effects of bar soap is to tailor the starting
fatty acid material such that higher chain-
length species are predominant.4lI 78 The for-
mulas also may contain a relatively high per-
centage of magnesium soap to enhance skin
mildness.65, 79 These tailored bars retain the

factant molecule, but this is not always ob- positive performance attributes of soap but
served in pra~tice.3~~ 53, 69 For a homologous offer a significant skin compatibility advan-
surfactant series, such as soaps produced tage over traditional soap bars and bars em-
from straight-chained fatty acids having chain ploying mixed soap and synthetic surfactant
lengths ranging from c8 to C2, there is usu- systems (Fig. 1).
ally a maximum in the volume of foam or Soap is neutral unless it is formulated with
lather produced as chain length increases.53 excess alkali or free fatty acid.34When a soap
This maximum typically occurs from Cl0 to is dissolved in water, small amounts of fatty
C,, and likely reflects a tradeoff between the acid and base are formed, the amounts being
factors that favor foaming and surfactant sol- governed by the equilibrium among these
ubility, which generally decreases with in- species, the dissolved soap, and water. Conse-
creasing chain length. quently, soap-based cleansers often exhibit a
Surfactant chain length also is a determi- higher pH than products based on synthetic
nant of soap’s undesirable properties, such as surfactants. This point has been used to advo-
its potential to irritate skin. KellumQ reported cate the use of synthetic-based cleansers over
that the most prominent irritation reactions soap-based cleansers, although some evi-
developed when fatty acids having chain dence suggests that synthetic surfactants may
lengths from c8 to C12were patched on skin. penetrate the skin more deeply and be more
Stillman et aln extended this work to include efficient at removing pH-stabilizing sub-
fatty acids having odd-numbered chain stances from the skin’s surface than soap.71
lengths and reported a similar result. The skin The skin’s surface normally is slightly
irritation potential of nonsoap surfactants acidic, giving rise to the concept of the so-
shows a similar chain-length dependency. called acid mantle, but surface pH values
Wilhelm et als2reported maximal increases in show regional and temporal variation.52, 84 In-

skin surface water loss, transepidermal water tact skin exhibits an ability to recover from
loss, and skin color reflectance for the C12 pH changes, even when exposed to highly
homologue in experiments conducted with a alkaline materials, although prolonged expo-
series of alkyl sulfates having chain lengths sure to materials applied under occlusion
of c8 to c16. Rhein et a1@,65 reported maximal may overwhelm the skin’s buffering
swelling of isolated stratum corneum mem- capacity.36, 71 Normal use of a soap-based

branes, a parameter linked to irritation poten- cleanser generally causes relatively minor al-
tial, for C12or C,, homologues in alpha olefin terations in skin surface pH. For example,
sulfonates, paraffin sulfonates, linear alkyl Gfatter et alZ9 reported a mean surface pH
benzene sulfonates, alkyl sulfonates, and al- rise of 0.45 units after infants’ skin was
kyl sulfates. Imokawa et aP8,39 showed a rela- washed with alkaline soap for 1 minute. Even
564 ERTEL

Dryness Erythema

Figure 1. Skin dryness and etythema produced by a soap bar based on a

tailored fatty acid mixture compared to that of a combination (soapkethionate)
bar and a traditional soap bar. Data were generated using a controlled forearm
wash method.13 These results demonstrate that it is possible to improve the
skin compatibility of soap-based bars by reducing the level of more irritating
fatty acid species.

the control (water) wash significantly raised
skin pH compared with the baseline value,
however. Bechor et all examined 41 marketed
skin-cleansing products covering a broad
compositional range and found that, on aver-
age, the skin surface pH increased by about
0.6 units after 30 seconds of washing (cheek
area) and returned to baseline within about
36 minutes. Even in the worst case, the sur-
face pH was raised by 1.3 units and recovered
within approximately 90 minutes. Sauermann
et a171 reported that the skin's surface pH
recovered 2 hours after a 5-minute wash with
soap. Korting et a147reported that skin surface
pH recovered within several hours after a 2-
minute wash of the forearm or forehead with
soap. These authors also noted a small (<1
pH unit) but persistent elevation in skin sur-
face pH at both body sites over a 4-week
use period involving twice daily, 2-minute
washing with soap.
Although washing may alter the pH of the
skin's surface, a cleansing product's pH ap-
pears to have little bearing on its potential to
damage skin. Robbins and Fernee'j6observed
no significant pH effect over a range from 3
to 9 on the epidermal membrane swelling
induced by many different surfactants. This
in vitro parameter has been shown to parallel
surfactants' in vivo irritation potential.'j*
Gehring et alZ7reported that a multi-compo-
nent emulsion with a pH value of 7.5 had a
greater drying effect on skin than a similar
emulsion with a pH of 4.5. Gfatter et alz9
postulated that repeated washing with soap
could disturb the acid mantle of infants' skin
and lead to drying, although their work also
showed that soap cleaned (removed sebum)
significantly better than the synthetic deter-
gents used, which also could lead to drying.
Bechor et al,' in addition to measuring the
change in skin surface pH, measured the
change in lipid level after washing. Their re-
sults show no significant relationship be-
tween the skin surface pH change and the
change in casual lipid level after washing.
Data presented by FroschE for 23 cleansers
marketed in the United States or Germany

similarly show no correlation between prod-
uct pH and the induction of scaling or ery-
thema. Work by van der Valk et alsoshowed
no evidence that cleanser pH was related to
its potential to cause skin irritation. Hassing
et a135reported similar results and postulated
that a product’s ability to clean (degrease)
or cause keratin denaturation has a greater
impact on its potential to damage skin than
its pH. As noted earlier, Korting et a147ob-
served that continued use of a soap bar in-
duced a persistent alteration in skin surface
pH. These authors reported a similar outcome
from experiments conducted with a liquid
cleanser formula adjusted to pH values of 5.5,
7.0, or 8.5 but concluded that the cleansing
preparation’s pH was not linked to its skin
irritan~y.4~Other workers have found no clear
relationship between a surfactant solution or
cleansing product’s pH and its potential to
irritate or dry skin, even under exaggerated
patch test conditions.%,56, 71 Cleansing prod-
ucts with a low pH often are shown to be
more irritating or drying than preparations
with a high pH. Thus, it seems that the skin
irritation potential of a personal cleansing
product is driven by the physical and chemi-
cal properties of its surfactants, not by its
pH.&
Marketed soap bars contain primarily wa-
ter-soluble sodium or potassium soaps. Dur-
ing washing, these soaps dissolve and pro-
vide the characteristic soap actions of dirt
removal and lather. While in solution, the
soluble soaps also can interact with other spe-
cies present in the wash water. In particular,
they may encounter calcium ion, which is the
predominant species contributing to water
hardness in many regions. The results is the
formation of insoluble calcium soap, which
deposits onto surfaces. This phenomenon is
responsible for the formation of soap scum.
More important, the calcium soap deposits
onto skin, where it can cause irritation.
The soap content of a cleanser and the
hardness of the water used for washing have
a significant impact on the product’s skin
compatibility. This was demonstrated in a se-
ries of controlled forearm wash studies con-
ducted to examine the effect of water hard-
ness on skin cleansers’ skin effects.15Products
covering a compositional range from com-
MODERN SKIN CLEANSERS 565
pletely synthetic surfactant based (non-soap
body wash) to completely soap based were
included. The test design comprised a series
of four studies pairing the following water
hardness conditions (total hardness in grains
per gallon [gpg]): 0 versus 7, 3 versus 7, 15
versus 7, and 23 versus 7. The data were
pooled and analyzed by an analysis of covari-
ance technique that used the 7 gpg data as a
covariant in a factorial design. As expected,
the results showed that at a given water hard-
ness value, a cleanser’s potential to dry skin
increases with increasing soap content. This
increase was true for visual dryness (Fig. 2)
and skin capacitance (Fig. 3), which provides
an instrumental assessment of stratum cor-
neum hydration. This study also showed that
a cleanser’s potential to dry skin is influenced
by water hardness conditions. For the visual
and instrumental endpoints, prodxts with a
higher soap content showed a greater ten-
dency to dry skin as water hardness in-
creased. The synthetic surfactant-based body
wash was the least drying and irritating of
the products tested, and its skin drying poten-
tial was independent of water hardness under
the conditions examined. This type of product
represents an option to provide mild skin
cleansing over a wide range of water hard-
ness conditions.
Synthetic Detergents
The term synthetic detergent describes non-
soap surfactants. Similar to their natural
counterparts, synthetic detergent molecules
have hydrophilic and hydrophobic regions
that give them the ability to localize at inter-
faces. In contrast to soap, a synthetic deter-
gent’s structure often is tailored to impart
specific properties to the molecule, including
the charge it carries. Several of the major
classes of synthetic detergents important in
the manufacture of skin-cleansing products
are considered in the following sections. A
more exhaustive discussion of synthetic de-
tergents is available in reports by S p i e ~ s ~ ~
and Rosen.68
Cocoyl Isethionate. Cocoyl isethionate is
the primary surfactant used in many mar-
keted bath and beauty bars. Similar to soap,
cocoyl isethionate is an anionic surfactant.
The hydrophilic group in isethionate, how-
ever, is a sulfonate rather than a carboxylate.
566 ERTEL

A Combination Bar

A
v /-
3-
//--
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/ -

. A
ge
Q
a,

.
/ / -

/ / / k c
3//------
/---A 2
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5:- z
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-- - l- ------. -0

.
A I
B-
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s!
-
0

--_
-
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---

Figure 2. Expert dryness assessment data from a series of arm wash studies
conducted with a range of personal cleansing products under different water
hardness conditions. These results show that a cleanser’s potential to dry skin
is dependent on its soap content and the water hardness conditions.
GPG = grains per gallon.

Cocoyl isethionate has excellent skin compati-
bility and is a good detergent and lime soap
dispersant (i.e., it inhibits the formation of
hard water scum).
Alkyl Sulfates. Alkyl sulfates are among
the most popular synthetic surfactants used
in the cosmetics and toiletries industry, being
found in products ranging from skin cleans-
ers to toothpaste. They are the primary sur-
factant in many marketed body washes, the
most commonly found form being the lauryl
sulfates. Alkyl sulfates are anionic surfac-
tants, have good foam-forming properties,
and produce a creamy lather, but they do not
perform well in hard water. Alkyl sulfates
have a marked potential to irritate skin. For
example, sodium lauryl sulfate has served as
a model irritant in numerous studies examin-
ing surfactant-skin interactions. The skin irri-
tation potential of alkyl sulfates shows a
chain-length dependency similar to that of
soap.64
Alkyl Ether Sulfates. Alkyl ether sulfates
are popular surfactants in the cosmetics and
toiletries industry and are present in many
liquid cleansing products as a primary or sec-
ondary surfactant. Alkyl ether sulfates offer
many advantages over alkyl sulfates, includ-
ing better foaming in hard water and better
lime soap dispersion. They also are less irri-
tating to skin than alkyl sulfates, their skin
compatibility being improved by a higher de-
gree of ethoxylati~n.~~?
79
Alkyl Glyceryl Ether Sulfonates. Alkyl
glyceryl ether sulfonates are anionic surfac-
tants used in bar and liquid personal cleans-
ing products. Alkyl glyceryl ether sulfonates,
such as sodium lauryl glyceryl ether sulfo-
nate, have marginal lathering characteristics
by themselves but may be combined with
secondary surfactants to boost lather. Alkyl
glyceryl ether sulfonates show good skin
compatibility and have good lime-dispersant
properties.
Betaines. Betaines belong to a class of sur-
factants called amphoterics-the charge on
these molecules depends on the pH of the
formulation they are in. The two types of
betaines most important in the formulation of
skin-cleansing products are alkyl betaines and
 MODERN SKIN CLEANSERS 567

0.04 I I I I I I

Q) 0.00
----
0

5
.- v
" .g5 -0.04
I ---------- -----
G3
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$ $ -0.08
= &
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o me
:--
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A Combination Bar
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-0.16 v Soap-Based Bar
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0 5 10 15 20 25
Total Water Hardness (gpg)

Figure 3. Skin capacitance (stratum corneum hydration) data from the same
series of arm wash studies conducted with a range of personal cleansing
products under different water hardness conditions. Consistent with the visual
dryness data, these results show that a cleanser's potential to dry skin is
dependent on both its soap content and the water hardness conditions.

the alkylamido betaines. They can improve
lather quality or be used to increase the vis-
cosity of liquid formulations. Betaines gener-
ally show good skin compatibility and can
decrease the skin irritation potential of
harsher anionic surfactants when used in
combination with them.l0,79 Cases of contact
allergy to cocamidopropyl betaine, one of the
most commonly used surfactants in this
group, have been reported9 Manufacturers
may be able to reduce the risk of contact
allergy by using a higher grade of betaine
material, because data suggest the allergic re-
sponse is caused by impurities rather than by
the surfactant itself.22,
Skin Conditioners
The addition of materials that provide skin-
conditioning benefits to personal cleansers is
not new. Superfatting, for example, was con-
ducted frequently as part of the traditional
soap-making process. It has only been rela-
tively recently that skin-conditioning agents
crossed the threshold from being mitigators
of irritation to providing true skin benefits,
however. The following are examples of skin
conditioning agents that may be found in
modern skin-cleansing products.
Superfatting
Superfatting is used to improve a cleanser's
skin compatibility, to improve lather quantity
or quality, or to impart specific in-use skin
feel characteristics to the finished bar. In tra-
ditional soap making, superfatting referred to
the addition of fatty acids in excess of the
amount required to react stoichiometrically
with the base during the soap-making pro-
cess. Modern superfatting processes employ
a variety of fatty materials, including triglyc-
erides, lanolin, paraffin, stearic acid, or min-
eral Although normally thought of only
in the context of soap bars, superfatting also
can be applied to synthetic detergent bars.
568 ERTEL
Glycerin
Glycerin has the ability to absorb moisture.
This property makes it a common ingredient
in leave-on moisturizer products, in which it
functions as a humectant. Glycerin has many
other effects on skin besides holding water,
however. Rawlings et aP3 showed that glyc-
erin enhances desmosomal degradation in
vitro, which may augment its skin-moisturiz-
ing properties. Glycerin also can act as a plas-
ticizing agent to improve the mechanical
properties of the skin, and there is evidence
that it may enhance the stratum corneum bar-
rier repair process.z,55, 57
Glycerin is a by-product of the triglyceride-
splitting process and is a natural component
of soap-based cleansing bars, usually present
at levels less than 6%.59It is also present in
many liquid cleanser formulations. Because
glycerin is miscible with water, a key chal-
lenge is to deliver and leave behind a sub-
stantive amount of glycerin during the wash-
ing and rinsing process. One approach that
has been used is to incorporate a higher level
of glycerin in a product (e.g., in cleansing
bars an amount >6%). At these higher levels,
it is possible to deliver a noticeable skin bene-
fit from a rinse-off product. For example,
Dahlgren et a17 compared two soap bar for-
mulations using an identical surfactant base.
One formula contained 10% glycerin, the
other no glycerin. Although controlled clini-
cal testing showed no significant difference
between the two formulations for a variety of
clinical endpoints, consumers rated the glyc-
erin-containing bar significantly better for
leaving their skin feeling moisturized, soft,
and smooth after use.
Polymers
Polymers, such as cellulose derivatives,
play many important roles in bar and liquid
skin cleansers. Apart from serving as formu-
lation aids, certain polymers have been
shown to be substantive on skin and to have
skin-protective properties.**,19, Polymers
also may be used to impart specific skin feel
characteristics, such as a slick rinse feel, or
to improve lather quality or creaminess. In
modern skin-cleansing products, polymers of-
ten are used in combination with other skin-
conditioning agents, such as glycerin or pet-
rolatum, to aid deposition of these materials
onto skin or to help mitigate their undesirable
skin feel characteristics.
Petrolatum
Many dermatologists recognize petrolatum
as an unsurpassed moisturizer, and the litera-
ture is replete with accounts of its utility as
an agent to improve and hydrate dry skin.
These properties often are attributed to petro-
latum’s occlusivity and its ability to impede
transepidermal water loss (TEWL). An eleva-
tion in TEWL rate is reported to be an im-
portant signal prompting barrier repair in
damaged skin,33which has led to speculation
that petrolatum application might impede
barrier repair. To the contrary, there is evi-
dence that petrolatum has the ability to accel-
erate the initial stages of barrier repair and
that topically applied petrolatum permeates
the stratum corneum and localizes in the in-
tercellular spaces, where it may affect lipid
bilayer 51 Furthermore, it appears
that petrolatum forms a semiocclusive barrier
on skin rather than being completely occlu-
sive. For example, Powers and reported
a 48% reduction in moisture loss after petrola-
tum was applied to the ventral forearm, and
L 0 d 6 n ~observed
~ a 57% reduction in TEWL
rate 1 minute after petrolatum was applied to
skin at a dose of 3 mg/cm2.
Incorporating a meaningful level of petrola-
tum into skin cleansers to provide a dry skin
benefit presents many formidable challenges.
Apart from issues related to depositing and
leaving behind petrolatum in the context of a
rinse-off product, factors such as processabil-
ity, stability, and product aesthetics must be
considered. In-use performance characteris-
tics, such as skin feel, need to be optimized
because petrolatum can impart a tacky skin
feel that consumers may find objectionable.
The introduction of body washes has pro-
vided formulators some additional degrees of
freedom, and they have developed a body
 MODERN SKIN CLEANSERS 569

wash product that contains a significant level
of emulsified petrolatum and has good es-
thetic proper tie^.^^ This product provides sig-
nificant improvements in dry skin appearance
and stratum corneum hydration 24 hours
after use (Fig. 4).
Other Ingredients
Modern skin-cleansing products contain a
variety of other ingredients that are present
in lesser amounts to provide additional bene-
fits, to improve esthetics, or to improve prod-
uct shelf life. These materials also can be a
problem source for patients. Some examples
of these ingredients are presented.
ponents. Apart from this masking function,
manufacturers may use fragrance to help es-
tablish brand character or to expand product
lines. Fragrance can provide a functional ben-
efit to the user. For example, stronger fra-
grances can provide deodorancy by masking
the body's odor. Recently there has been a
focus on using fragrances to deliver higher-
order benefits, such as altering the user's
mood during bathing or showering.
Fragrances frequently are implicated as a
cause of contact dermatitis and as a potential
triggering factor for patients with predispos-
ing skin conditions, such as atopic dermatitis.
Studies have shown that even patients with
atopic dermatitis can tolerate the use of
scented skin-cleansing products, h~wever.~, l4

This apparent contradiction likely reflects that

Fragrance
Fragrance usually is present at a very low
level in skin cleansers, but it plays many im-
portant roles. From a formulation standpoint,
a fragrance masks the characteristic and often
unpleasant base odor of other formula com-
unwanted dermatologic effects are triggered
by specific fragrances or fragrance compo-
nents. The difficulty facing consumers and
dermatologists is that manufacturers rarely
identify a specific fragrance on product label-
ing, much less its component^.^^
The number of unscented and fi grance-free

I ~ I ~ I 'I I ' I I

-- 0 3 Hours Post-Wash
----_ 0 24 Hours Post-Wash

---I---------

--
i------
z

- \

I I I I I I I

0 48 96 144 192 240 288

Study Hours

Figure 4. Dry skin improvementfrom once-daily treatment with a body wash containing emulsified petrolatum
over a period of 14 days. The improvement in dry skin is significant, even 24 hours after the wash. Skin
capacitance measurements show a corresponding and significant improvement in stratum corneum hydra-
tion. (Data from Ertel KD, Neumann PB, Hartwig PM, et al: Leg wash protocol to access the skin moisturiza-
tion potential of personal cleansers. Int J Cosmet Sci 21 :383-397,1999.)
570 ERTEL
skin cleansers available to consumers has in-
creased, but these designations often are a
source of confusion rather than reassurance,
in part, because neither unscented nor fru-
grunce free currently has a legal definition.u,
48, 74 A product designated as unscented may
contain a low level of fragrance to mask the
base odor of other formula components, and
fragrance-free cleansers must not contain a
specific fragrance component.6 The latter
products sometimes contain ingredients such
as preservatives or natural oils that provide
scent as a secondary function, however. Such
ingredients can be a covert source of
dermatitis.73,74 Unscented and fragrance-free
products require extra diligence on the part
of the dermatologist who is seeking a skin
cleanser to recommend for fragrance-sensitive
patients.
Antibacterial Agents
Triclocarban and triclosan are antibacterial
agents found in many marketed cleansing
bars and liquids. These compounds are in-
tended to provide a health benefit beyond
simple washing; however, showing this addi-
tional benefit has proved a difficult task. This
difficulty may be due, in part, to the fact that
the effectiveness of washing as an interven-
tion is itself variable, even in a controlled,
hospital en~ironment.~ Studies have shown a
potential added health benefit from using an
antibacterial soap in patients with atopic der-
matitis, and risk-assessment modeling sug-
gests that this benefit may be applicable to
other situations involving skin infe~tion.~, z7*67
Preservatives
A preservative’s role is to inhibit the
growth of microorganisms in a skin-cleansing
product. These materials are particularly im-
portant in liquid skin cleansers, which con-
tain higher levels of water than bars and are
more likely to support microbial growth. Al-
though usually present at a relatively low
level in skin-cleansing products, preservatives
should not be overlooked as a possible prob-
lem source for patients because some of
these materials have a potential to cause
sensitization.8,58
Implements
Although not a formula component, imple-
ments are an integral part of the cleansing
process. Consumers usually have applied
cleansing bars with the hand or a washcloth,
but many body washes are intended for ap-
plication with a mesh cleansing puff and of-
ten are sold as systems with these imple-
m e n t ~These
. ~ ~ puffs provide an invigorating
washing experience, and the mesh material is
an excellent environment for efficiently mix-
ing body wash, water, and air. As a result,
the combination of body wash and puff yields
copious amounts of lather and improved
scent bloom, both of which enhance the user’s
cleansing experience. The lather-generating
characteristics of the puff allow formulators
of body wash products to focus more atten-
tion on enhancing skin benefits and less on
product lather performance.
Implements can alter the skin’s surface and
have an impact on the skin effects produced
by cleansers. For example, implements that
damage the stratum corneum barrier can in-
crease a product’s potential to damage
skin.’” 43 Given this potential and the growing
popularity of body washes, a leg wash study
was conducted to assess the cleansing puff’s
impact on the skin effects produced by these
products. A regular body wash was used to
avoid confounding effects that might be intro-
duced by a moisturizing cleanser, such as ob-
scuring dryness endpoints. A marketed
cleansing puff was and hand applica-
tion was chosen as a comparative benchmark
because it provides a consistent, consumer-
relevant standard. Ten female subjects had
one leg washed with the cleansing puff and
the other with the hand. Implement assign-
ments were randomized. Subjects’ legs were
washed in a controlled manner twice daily
over a period of 4 days. The twice-daily fre-
quency was chosen as a reasonable upper
limit for expected consumer use. Subjective
and objective endpoints were used to assess
skin condition at baseline and 20 hours after
the final study wash.
Expert assessments of visual dryness and
erythema showed a rank-order advantage for
cleansing puff application over hand applica-
tion. The instrumental endpoints were more

revealing (Table 1).Measurements of TEWL
rate and skin capacitance showed a signifi-
cant advantage for cleansing puff application
over hand application, indicating that
applying product with the puff resulted in
less barrier damage and a smaller reduction
in stratum corneum hydration (less drying).
Consistent with this, the desquamation in-
dex:* based on image analysis of D-Squame
(CuDerm, Dallas, TX) samples taken from the
legs, showed a significant advantage for
cleansing puff application. Subjects also per-
ceived that cleansing puff application of the
product left their legs smoother than hand
application. These results indicate that using
a cleansing puff to apply body wash does
not increase skin irritation. To the contrary, it
appears that the cleansing puff may provide
benefits in terms of reducing a product’s po-
tential to irritate skin and to dry skin. These
benefits may be a direct effect of the puff by
mild exfoliation that reduces dryness, or they
may be an indirect effect resulting from more
efficient lather generation that lowers the ef-
fective concentration of surfactant at the
skin’s surface.
Assessing Cleanser Skin Effects
As the number of skin cleanser options has
expanded, so too have the number of meth-
ods used to predict their effect on skin. Until
about 2 decades ago, the primary question
was whether a cleansing product was irritat-
ing to skin or not. This question usually was
assessed by simple patch test. Then, in 1979,
Frosch and Kligmanz6presented their soap
chamber test. This opened a new era in skin
cleanser testing because under this method it
was possible not only to predict if a product
was irritating to skin, but also to rank its
Table 1. MEAN TRANSEPIDERMAL WATER LOSS RATE, SKIN CAPACITANCE, AND DESQUAMATION INDEX
CHANGES MEASURED FOR A NONMOlSTURlZlNG BODY WASH APPLIED WITH THE CLEANSING PUFF OR
THE HAND*
TEWL Rate
-
(g/mz hr)
Cleansing puff 1.25
Hand 1.96
*All of these endpoints showed a significant (P<O.lO) advantage for cleansing puff application over hand application.
TEWL = transepidermal water loss.
MODERN SKIN CLEANSERS 571
irritation potential relative to that of other
products. Marketers quickly seized on this
and other test methods as an opportunity to
promote their products over those of competi-
tors.
The soap chamber test employs highly ex-
aggerated exposure conditions to induce skin
reactions, and the potential pitfalls of this
testing approach quickly became apparent. In
1982, FroschZ5noted disparities between the
relative irritation potential predicted for skin
cleansers tested under the soap chamber test
and protocols employing more consumer-rel-
evant exposure conditions. Since then, many
workers have reported similar findings, and
it now is generally recognized that the skin
effects predicted for a skin-cleansing product
are highly dependent on the test conditions
used to make the prediction. Although more
exaggerated exposure conditions may yield
better product discrimination, they can lack
consumer relevance and introduce factors
that confound results. For example, the au-
thor previously reported on a study compar-
ing two antecubital wash protocols.16 One of
the protocols employed relatively mild expo-
sure conditions and the other aggressive ex-
posures that can breach the stratum corneum
barrier. The latter protocol predicted a sig-
nificant irritation potential for a lotion with
skin-healing properties, an outcome that
clearly is inconsistent with consumer experi-
ence for this type of product.
Simple patch tests no longer are adequate
to characterize the wide range of skin effects
modern skin-cleansing products may induce.
Consumer use provides the best conditions
for gauging a cleansing product’s effects on
skin, and long-term studies in which a test
product is substituted for subjects’ usual
cleanser may be conducted for this purpose.
The length, cost, and inherent variability of
such designs limit their value as a predictive
Log Skin Capacitance Desquamation
- 0.030 0.034
- 0.079 0.054
572 ERTEL
tool during product development, however.
For this reason, the scientific and manufactur-
ing communities have tended to rely on rela-
tively short-duration, controlled exposure
protocols to predict cleansers’ in-use skin ef-
fects. For reasons noted previously, the chal-
lenge of this approach is choosing an expo-
sure model that is relevant to expected
consumer use.
Developing cleanser formulas that mini-
mize skin irritation has been a primary focus
of the personal cleansing industry. Because
consumer use habits vary widely for these
products, methods used to predict a cleansing
product’s skin irritation potential should em-
ploy exposure conditions that reflect a reason-
ably foreseeable level of overuse. To this end,
a controlled forearm wash method is a useful
tool for predicting personal cleansers’ skin
irritation potential.50The exposure conditions
used in this method are based on observa-
tions of consumer washing. The frequency of
washing, four daily exposures, is somewhat
exaggerated beyond the bathing or showering
frequency experienced by most consumers.
This higher exposure frequency enhances the
protocol’s ability to discriminate products on
the basis of their skin effects, however. The
author generally has found good agreement
between product rank orderings predicted by
this protocol and those observed under condi-
tions of home use.43
A multiple treatment site version of this
arm wash protocol called the forearm con trolled
application technique (FCAT) has been re-
ported.I3 Under the FCAT protocol, eight
products can be tested simultaneously on a
single subject. Apart from obvious cost effi-
ciencies, this design offers several other ad-
vantages when more than two products are
tested, including greater precision and sensi-
tivity than typical two-sample models. This
advantage in part is due to the fact that the
FCAT design minimizes intersubject variabil-
ity. As a result, the FCAT protocol provides a
robust, reliable tool for predicting the poten-
tial for skin-cleansing products to dry or irri-
tate skin.
Body wash products have expanded
greatly the range of skin effects that is possi-
ble from personal cleansers. Although formu-
lating to minimize skin irritation potential re-
mains a primary goal, there is now a greater
emphasis on developing products that deliver
a skin improvement benefit. In many cases,
the objective is to improve dry skin, which is
a key consumer signal of the need to use
moisturizer.61Body wash products are avail-
able today, such as the product shown in
Figure 4, that deliver against this objective.
The dilemma from a clinical testing stand-
point is that traditional test protocols that
employ exaggerated exposure conditions may
obscure a product’s skin benefit. Dry leg pro-
tocols of the type used to test products such
as leave-on moisturizers also are not directly
applicable to skin cleansers because the use
patterns for these products are different.
A leg wash protocol has been developed
that can be used to assess the personal cleans-
ers’ potential to provide a dry skin benefit.17
Healthy women with clinically normal skin
are recruited as subjects. The study design
comprises two phases. The first is a 1-week
preconditioning period, during which sub-
jects stop using all moisturizers on their legs
and leg shaving is restricted. Some leg proto-
cols use exaggerated soap washing to induce
dry skin, but restricting moisturizer is suffi-
cient to induce dry skin in most subjects.
Exaggerated soap washing can damage skin
and may alter the skin’s response to other
applied materials, and thus represents a po-
tential confounding effect. Under this proto-
col, subjects are provided with a mild cleans-
ing bar to use in place of their normal product
for bathing and showering but are prohibited
from using the bar or its lather directly on
the legs at any time during the study.
Subjects exhibiting a required level of dry
skin at the end of preconditioning continue
into the second phase of the study, the treat-
ment phase, which is a minimum of 5 days
in length. Treating over multiple days allows
assessment of cumulative product skin ef-
fects. Subjects’ legs are washed in a controlled
manner once or twice daily, the latter repre-
senting a reasonable upper limit for consumer
showering frequency. The leg wash can be
conducted using a paired or Latin square de-
sign, but in contrast to the FCAT discussed
previously, a maximum of two treatment sites
per leg is used when testing marketed prod-
ucts to accommodate application with a

cleansing puff, because label directions for
some marketed products specify that this im-
plement be used. Because dry skin condition
can change rapidly in response to weather,
all designs include an appropriate control to
account for changes in skin condition not
caused by treatment effects.
Leg skin condition is assessed by visual
and instrumental evaluations conducted at
baseline, 3 hours after the first wash, before
the first wash on the second and fifth days,
and 3 hours after the final wash on the fifth
day. Studies with longer treatment periods
incorporated additional evaluation visits at
similar time intervals. Subjects acclimate un-
der controlled environmental conditions for a
minimum of 30 minutes before each evalua-
tion. Short-term product benefits are charac-
terized after a single use and after several
days’ use as well as longer-lasting benefits
after approximately 24 hours, which is consis-
tent with consumer showering habits. Similar
to the FCAT protocol, the author has found
this leg protocol is a robust and reliable tool
for assessing personal cleansers’ skin effects.
SUMMARY
The course of development of skin cleans-
ers has been one of continual improvement.
Soap-based products, used since antiquity, of-
fered improved cleansing over mechanical
methods or water alone but could irritate and
dry skin. Bars based on synthetic detergents
that offer improved skin compatibility com-
pared with soap have become available over
the past several decades. Body washes have
been growing in consumer popularity. Some
of the first body washes introduced into the
market offered a moisturization benefit in ad-
dition to mildness. Some second-generation
body washes that are now on the market use
even more sophisticated formulation
schemes, such as coacervate technology, to
deliver emulsified petrolatum to the skin dur-
ing washing, providing mild cleansing and
a significant dry skin improvement benefit.
Consumer demand and the formulation pos-
sibilities provided by new product formats,
new technologies, and new ingredients will
MODERN SKIN CLEANSERS 573
undoubtedly lead to the delivery of even
greater skin benefits in the future.
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