JDV002.

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JEADV (2001) 15 (Suppl. 1), 5–11

OR I G I N AL AR T I C LE

Skin benefits from continuous topical administration of a zinc

Blackwell Science, Ltd

oxide/petrolatum formulation by a novel disposable diaper

S Baldwin,†* M R Odio,† S L Haines,† R J O’Connor,† J S Englehart,† A T Lane‡
†Procter & Gamble Co., Cincinnati, OH, ‡Stanford University School of Medicine, Palo Alto, CA, USA. *Corresponding author: Procter & Gamble Co.,
11450 Grooms Road., Cincinnati, OH 45242, USA. tel. +1 513 626 1848; fax +1 513 626 2652; E-mail: Baldwins@pg.com

ABSTRAC T
Background Diaper dermatitis is a common childhood affliction. Aiming to help reduce the prevalence
of this problem, we have advanced in our development of a novel diaper that delivers dermatological
formulations to help protect the skin from over-hydration and irritation.
Objective To determine the clinical benefits of a novel disposable diaper designed to deliver a zinc oxide and
petrolatum-based formulation continuously to the skin during use.
Methods All studies were independent, blinded, randomized clinical trials. Study A was conducted to
confirm transfer of the zinc oxide/petrolatum (ZnO/Pet) formulation from the diaper to the child’s skin
during use. Children wore a single diaper for 3 h or multiple diapers for 24 h. After the use period, stratum
corneum samples were taken from each child and analysed for ZnO/Pet. Study B evaluated the prevention
of skin irritation and barrier damage from a standard skin irritant (SLS) in an adult arm model. Study C
evaluated skin erythema and diaper rash in 268 infants over a 4-week usage period. One half of the infants
used the ZnO/Pet diaper, while the other half used a control diaper that was identical except for the absence
of the ZnO /Pet formulation.
Results The ointment formulation and ZnO transferred effectively from the diaper to the child’s skin during
product use. Transfer of ZnO increased from 4.2 µg/cm2 at 3 h to > 8 µg/cm2 at 24 h. Exposure to the
formulations directly on adult skin prior to an irritant challenge was associated with up to a 3.5 reduction
in skin barrier damage and skin erythema. Greatest reductions were seen for the ZnO containing formula-
tions. Wearing of the formulation treated diaper was also associated with a significant reduction in skin
erythema and diaper rash compared to the control product.
Conclusions The results demonstrated the clinical benefits associated with continuous topical administra-
tion of a zinc oxide/petrolatum-based formulation by this novel diaper.
Key words: napkin rash, diaper rash, zinc oxide petrolatum, irritation, erythema

In the mid-1980s, Berg 6 proposed a model to describe the

Introduction
Diaper dermatitis is among the most prevalent cutaneous
disorders of infancy and early childhood1 and, as many parents
will attest, can be a source of significant discomfort and distress
for the child. This term is generally not used in a specifically
diagnostic sense but rather, is intended to denote a host of acute
inflammatory reactions which arise from a combination of
variables associated with the use of diaper.1,2 Reports in the
literature estimate the prevalence of this condition at between
25 and 65% of children3,4 and also document that, although it
can occur at any point during the diaper-wearing years, it tends
to peak around 6 – 12 months of age.4,5
manner in which key variables associated with diaper wear might
interact to promote the development and progression of diaper
dermatitis. This model proposes that irritant diaper dermatitis
develops as a cascade of events initially triggered by damage to the
stratum corneum induced by exposure to overhydration, fric-
tional damage and increased irritancy of the urine / faeces mixture
due to pH changes. Once the skin barrier has been compromised,
additional insults of this same type become magnified in their
adverse impact upon skin integrity, thus triggering a vicious circle
of increasing damage which, if left unbroken, can lead to severe
forms of irritant dermatitis, predisposing to opportunistic
infection by organisms such as Candida albicans, etc.7– 9

© 2001 European Academy of Dermatology and Venereology 5

JDV002.fm Page 6 Friday, August 31, 2001 11:49 AM
6 Baldwin et al.
A lasting, beneficial impact of Berg’s contributions2 is that
they provided a road map to guide innovations in disposable
diaper design aimed at reducing the impact of the variables
that initiate the diaper dermatitis cascade. This includes the
use of superabsorbent polymers and softer, less abrasive
materials to reduce skin overhydration and frictional damage
to the epidermis. Evidence from clinical studies conducted
in North America10,11 and in Western Europe12 – 14 indicates
that, compared to cloth or early cellulose products, these
modern diapers are associated with significant reductions
in skin wetness, closer to normal skin pH, and demon-
strable reductions in the frequency and severity of diaper
dermatitis.
Further enhancements to diaper design that have lead to
additional benefits to infant skin have been reported by
Odio.15,16 The use of a petrolatum formulation on a diaper
as a means to further protect the stratum corneum from
irritant, hydrational and frictional insults was shown to prevent
skin irritation and diaper rash during regular use of the
formulation-containing diaper. The present work describes
a further innovation in diaper design consisting of a product
capable of delivering both zinc oxide and petrolatum to the
child’s skin during normal use of the diaper. Zinc oxide is
often used in skin care products and for the protection against
skin irritation. The present work describes the results of three
clinical studies which clearly support the approach of delivering
a combined zinc oxide/ petrolatum formulation continuously
via a diaper constitutes an effective means to improve the
condition of the skin under the diaper.
Materials and methods
Subjects
Studies A and C
Children who were routine users of disposable diapers, in
good health as shown by medical history and dermatological
examination at the enrolment visit, and whose parent/legal
guardian provided written informed consent for participation,
were recruited for the studies. Parents were informed of their
right to withdraw their children from participation in the
studies at any time. Due to the difficulties of scoring erythema
(a key end-point in these studies) in darker skin, enrolment
in Study C was restricted to children with skin types I–IV on
the Fitzpatrick scale.23 The average ages of children in
these studies were as follows: Study A: 15.2 months; Study
C: 9.9 months.
Study B
Twenty adult females between the ages of 18–45 years, in
general good health and with no evidence of dermatological
conditions or damage to the arms were recruited for this study.
All three studies were conducted at accredited Clinical Research
© 2001 European Academy of Dermatology and Venereology JEADV (2001) 15 (Suppl. 1), 5–11
Organizations (CROs) and received review and approval by
each facility’s Institutional Review Board (IRB).
Control and test materials
The control diaper used in Studies A and C was a commercially
available, premium quality product containing a super-absorbent
(AGM)/cellulose core and breathable outer cover which was
obtained directly from our manufacturing lines (Procter
& Gamble Co., Cincinnati, OH, USA). The test diaper was
identical in every respect to the control except for the inclusion
of a topsheet (inner layer) impregnated with a proprietary
formulation containing primarily petrolatum, stearyl alcohol
and zinc oxide in combination (ZnO/Pet). The test materials in
the adult arm study were 7.5% zinc oxide in petrolatum/stearyl
alcohol-base formulation (7.5% ZnO/ Pet), 40% zinc oxide in
petrolatum/stearyl alcohol-base formulation (40% ZnO/ Pet)
and a petrolatum/stearyl alcohol (Pet) formulation without the
zinc oxide.
Design of studies
Study A: Zinc oxide and total ointment delivery to the skin
This was a randomized, double blind trial where panellists and
analytical personnel were unaware of the treatment. All infants
enrolled in the study wore a formulation-free diaper for 3 days
(‘washout’) and parents were instructed to suspend use of any
ointments, creams, powders or any other diaper rash or skin
care products on the diapered areas of their children for the
entire duration of the study. The parents were allowed to maintain
the normal bathing and hygiene routines of their children except
that they were asked to use a standard disposable infant wipe
(Pampers Baby Fresh™, Proctor & Gamble Co.), which was
supplied to them, in lieu of their usual wipe or washcloth.
Upon completion of a 3-day washout period, infants were
assigned to one of two groups. Group 1 consisted of 27 infants
who wore a single ZnO/Pet formulation diaper for 3 h. Group
2 consisted of 40 infants who wore multiple ZnO/Pet diapers,
according to parental changing habits, over a period of 24 h.
At the end of the designated time period, diapers were removed
and a Tegaderm™ tape strip (3M, St. Paul, MN, USA) was taken
from six sites: two lower buttocks, two leg crease, two perianal.
A formulation-free diaper was then applied to the infant for
10 min to ensure adherence of the tape. Following the 10 min,
the tapes were removed and analysed for either zinc oxide or
total ointment. Additionally 22 randomly selected infants
continued to wear formulation-treated diapers for 3 days after
which they were switched to a formulation-free diaper. Tape
strips were taken from the buttocks 24 and 48 h after discontin-
uing use of the formulation-treated diaper.
Zinc oxide was analysed using inductively coupled plasma
atomic emission spectrometry (ICP-AES). Total ointment
was measured by gas chromatography analysis of stearyl
JDV002.fm Page 7 Friday, August 31, 2001 11:49 AM
alcohol. Data from Study A were converted to µg formulation or
ZnO per cm2 of skin and reported as group averages.
Study B: Protection against irritant insults by
the ZnO-Pet ointment
This randomized, blinded clinical trial included 19 adult
female volunteers between the ages of 18–45 years. Panellists
were in general good health and presented no evidence of
dermatological conditions. In order to facilitate more accurate
evaluation of skin erythema, the panellists were of Fitzpatrick
skin types I–III. Upon entry to the study, skin sites on each
upper arm were demarcated. Subjects were acclimated for
30 min in a temperature (22 ± 1 °C) and humidity (40 ± 5%
RH) controlled room. After acclimation, baseline erythema
scores and transepidermal water loss (TEWL) measurements
were taken using a DermaLab® evaporimeter at each of the
demarcated skin sites. Panelists received all skin pretreatments,
which were randomly assigned and applied to the test sites and
included (amount applied to skin):
• 7.5% ZnO in Pet* formulation (0.2 mg /cm2);
• 7.5% ZnO in Pet formulation (5.0 mg /cm2);
• 40% ZnO in Pet formulation (0.2 mg /cm2);
• 40% ZnO in Pet formulation (5.0 mg /cm2);
• Pet formulation (0.2 mg/ cm2);
• Pet formulation (5.0 mg/ cm2);
• control – no pretreatment with a formulation.
*Pet formulation is a mixture of petrolatum and stearyl alcohol
Following pretreatment, all sites received application of an
occlusive patch impregnated with 0.3 mL of a 0.5% w/v solu-
tion of the irritant sodium lauryl sulphate (SLS). The patches
were removed 24 h after application and subjects were once
again acclimatized for 30 min under the controlled temperature
conditions. Following this acclimation period, erythema scores
and TEWL measurements were taken at all skin sites, and this
procedure was repeated daily over the next 4 days. Erythema
was graded using a 4 point scale: 0 (no erythema), 1 (mild),
2 (moderate), 3 (severe), and 4 (severe erythema with vesicles
or eschar formations). Study B was analysed using analysis of
variance (ANOVA). TEWL measurements were analysed using
the area under the curve across the study duration. A probability
of ≤ 0.05 was used as the criterion for statistical significance.
Study C: effect of ZnO-Pet formulation-containing diaper
on infant skin erythema and diaper rash
This was a randomized, double blind, parallel group com-
parison trial designed to evaluate the effect of the test diaper
on the diaper rash profile of children during a 4-week period
of use of the control or test products. Children in general good
health as determined by medical history, and with no evid-
ence of serious or chronic disease upon initial dermatological
examination were eligible to participate in the study. Sub-
jects were excluded from the study if they had severe diaper
© 2001 European Academy of Dermatology and Venereology JEADV (2001) 15 (Suppl. 1), 5 –11
Zinc oxide/petrolatum-containing napkin and infant skin condition 7
rash that appeared to require physician treatment. Parents
of all eligible children were given a 1-week supply of the
control product and instructed to use only this diaper until
the next scheduled visit 6 days later (‘washout’ period). At
the completion of the ‘washout’ period, 304 children were
randomly allocated to one of two treatment groups after a
baseline dermatological examination of the diaper area.
Randomization was by gender and diaper rash grade. Children
in Group 1 were assigned to continue on the control product
and children in Group 2 were assigned to use the test diaper.
Each group consisted of approximately 50% males and females.
All parents were instructed to diaper their child exclusively
with the product assigned to him/her, and to avoid the use of
any ointments, creams, powders or any other diaper rash or
skin care products on the diapered areas of their children for
the entire duration of the study. The parents were allowed to
maintain the normal bathing and hygiene routines of their
children except that they were asked to use a standard disposable
infant wipe (Pampers Baby Fresh™, Proctor & Gamble Co.),
which was supplied to them in lieu of their usual wipe or wash-
cloth for diaper changing needs. These allowances and restric-
tions were intended to permit the evaluation of the diaper
under normal hygiene practices for each child, but without
the possible confounding influences of other products intended
to protect the skin or improve its condition. Parents were
instructed to change their child into a clean diaper approxi-
mately 2 h prior to each subsequent scheduled visit to the clinical
site. The children returned to the clinical site twice per week
(Monday/Thursday or Tuesday/Friday) over the next 4 weeks,
for a total of eight postbaseline visits. At each of these visits, the
skin in the diaper area of each child was examined for the pres-
ence of rash and erythema. Diaper rash and erythema were
scored throughout the entire study by a trained skin evaluator.
The skin grader was blinded as to the diaper assignment of
each child. The scoring of diaper rash and erythema was done
according to the scale given below. Erythema scoring only
included the skin pink/redness portion of the scale. An
important component of the scale is that it incorporates
surface area as a key element in the definition of the severity of
the irritation. Study C is reported as group averages and was
analysed using analysis of variance (ANOVA) with baseline
scores used as covariate. A probability of ≤ 0.05 was used as the
criterion for statistical significance.
Results
Study A
The results are shown in fig. 1. The figure shows that the zinc
oxide effectively transferred from the diaper to the skin during
normal use of the product and increased over the 24-h internal
during which the test diapers were worn. Furthermore,
following cessation of diaper use, the zinc oxide was no longer
JDV002.fm Page 8 Friday, August 31, 2001 11:49 AM
8 Baldwin et al.
(a) Zinc Oxide Delivery
15 3 hours 15
24 hours
ZnO µg/cm 2
10
10
ZnO - µg/cm 2
5
5 ND
0 0.3
0 Days After Diaper Use
Perianal Buttocks Leg Folds
fig. 1 Topical deposition of zinc oxide to infant skin. (a) Transfer of zinc oxide
to skin after wearing formulation-treated diapers for 3 h (single diaper) or
24 h (multiple diapers). Each bar represents Mean zinc oxide amount ± SEM
for 27 infants (3 h) and 40 infants (24 h). (b) Amount of zinc oxide remaining
on skin 24 and 48 h after discontinued use of formulation-treated diapers.
Mean zinc oxide amount ± SEM for 22 infants. ND = non-detectable.
fig. 2 Prevention of skin barrier damage by pretreatment with zinc oxide/
petrolatum or petrolatum-containing formulations following 24-h exposure
to SLS. Each data point is the Mean ± SEM of 18–19 observations.
Significant difference (P < 0.05) from: * = control (no pretreatment) and
petrolatum formulation (no zinc oxide); α = control only; β = petrolatum
formulation only.
present in the upper stratum corneum by day 2, indicating that
the zinc oxide does not accumulate. The data demonstrated that
the total formulation transfer amount was consistent with
previously reported data for the petrolatum-alone formulation
diaper (data not shown).15 Based on total formulation delivery,
topical delivery of zinc oxide was proportional to its con-
centration in the formulation (7.5%).
Study B
Pretreatment of skin sites with 5.0 mg /cm2 of zinc oxide in the
petrolatum formulation resulted in a significant reduction in
SLS-induced skin damage. Figures 2 and 3 show that barrier
damage as measured by TEWL and erythema was significantly
reduced for both the 7.5% and 40% zinc oxide formulations
compared to the untreated control and the petrolatum (without
2 2
(b) Zinc Oxide Removal 1.2 (a) 5 mg/cm application 1.2 (b) 0.2 mg/cm application
Average Erythema Severity
After Diaper Use
0.9 0.9
0.6 0.6
* *
ZnO/Pet
Pet
7.5 % ZnO/Pet
Pet formula
Pet. formula
0.3
7.5 % Zn/Pet
40 % ZnO
2
40 % Zn/Pet
↑ 1
Control
Control
End Use
0.0 0.0
fig. 3 Prevention of skin erythema by pretreatment with zinc oxide/
petrolatum or petrolatum-containing formulations following 24-h exposure
to SLS. Each data point is the Mean ± SEM of 18 – 19 subjects. * indicates
significant difference (P < 0.05) from control (no pretreatment) and
petrolatum formulation (no zinc oxide).
ZnO) formulation. The petrolatum-alone formulation pro-
vided a significant improvement over no pretreatment when
assessed by TEWL. At the lower application level of 0.2 mg/cm2,
the combination of zinc oxide and petrolatum showed an
improvement in TEWL and erythema, which was not apparent
for the petrolatum-alone formulation. At the lower application
amount there was a zinc oxide concentration-dependent effect
in terms of preventing skin damage, which was not observed
when the formulation was applied at the higher amount.
Study C
This study entailed a 4-week evaluation of the test diaper to
determine whether it could reduce the severity of diaper
dermatitis (skin erythema and rash) (Table 1). The results are
summarized in figure 4. As shown in the figure, there was a
significant reduction in the severity of erythema / diaper rash at
all four sites among infants using the test diaper compared to
children assigned to the control. The proportion of visits where
no erythema or diaper rash (grade = 0) was observed was
significantly reduced for the test group at three of the four skin
sites. Genital and buttock results are shown in figure 5.
As a general observation, the rash scores varied markedly
over time in both treatment groups. In spite of this variation,
the results in figures 4 and 5 showed a clear reduction in diaper
dermatitis among children using the test diaper compared to
the control diaper throughout the duration of the study. The
persistence of the reduction of rash severity among users of the
test diaper throughout the entire 4-week duration of the study
substantiates that the test diaper effect was not sporadic or
short-lived.
Discussion
These studies substantiate the effectiveness of this novel
disposable diaper for the topical delivery of a zinc oxide/
petrolatum-based formulation as a means of reducing the
contact irritation problems associated with diaper use.
© 2001 European Academy of Dermatology and Venereology JEADV (2001) 15 (Suppl. 1), 5–11
JDV002.fm Page 9 Friday, August 31, 2001 11:49 AM

Zinc oxide/petrolatum-containing napkin and infant skin condition 9

Table 1 Napkin rash and erythema scoring scale

Score Degree Definition

0 None Skin is clear (may have some very slight dryness and /or single papule but no erythema)
0.5 Slight Faint to definite pink in a very small area (< 2%); may also have single papule and /or slight dryness
1.0 Mild Faint to definite pink in small area (2–10%) or definite redness in very small area (< 2%) and /or scattered papules and/or
slight dryness/scaling
1.5 Mild/ Moderate Faint to definite pink in larger area (10%) or definite redness in a small area (2–10%) or very intense redness in small
area (< 2%) and /or scattered papules (< 10% area) and /or moderate dryness/scaling
2.0 Moderate Definite redness in larger area (10–50%) or very intense redness in very small area (< 2%) and /or single to several areas
of papules (10–50%) with 0–5 pustules, may have slight desquamation or oedema
2.5 Mod/ Severe Definite redness in very large area (> 50%) or very intense redness in small area (2–10%) w/oedema and/or larger areas
(> 50%) of multiple papules and /or pustules; may have moderate desquamation and /or oedema
3.0 Severe Very intense redness in larger area (> 10%) and /or severe desquamation, severe oedema, erosion and ulceration; may have
large areas of confluent papules or numerous pustules/vesicles

0.6 (a) Genital 1.2 (b) Perianal

60 Control Diaper
* ZnO/Pet Diaper
*
Severity of Diaper Rash

Percent of Total Visits

1.0
0.4

0.8
50
0.2
0.6
*
0.0 0.4
40 *
4 8 11 15 18 22 25 29 4 8 11 15 18 22 25 29
Baseline
Baseline

30
0.6
(c) Buttocks 1.2 (d) Leg Folds
Severity of Diaper Rash

* 1.0
20
0.4 * Genitals Buttocks
0.8
fig. 5 Proportion of visits with diaper dermatitis using control or ZnO/Pet
0.2 formulation-treated diapers. Each data point represents the Mean Diaper
0.6
Rash Score ± SEM of 127 – 141 children. The cross-hatched bars indicate
children using the control product; the solid bars indicate children using the
0.0 0.4
4 8 11 15 18 22 25 29 4 8 11 15 18 22 25 29 formulation-treated diaper. * indicates a statistically significant difference
Baseline
Baseline

Study Days Study Days (P < 0.05) between the control and treatment groups.

Control Diaper ZnO/Pet Diaper

fig. 4 Reduction in severity of diaper dermatitis among children using

control or ZnO/Pet formulation-treated diapers. Each data point represents The results from Study B provide evidence in a controlled
the Mean Diaper Rash Score ± SEM of 127 – 141 children. The open circles adult model that the ZnO/Pet formulation can prevent skin
indicate children using the control product; closed circles indicate children damage when skin is exposed to irritants. The skin within
using the formulation-treated diaper. * indicates a statistically significant the diaper is exposed to irritant insults from urine and faeces.
difference (P < 0.05) between the 2 curves.
The ability to protect against these irritants is an important
step in preventing a cascade of skin damaging effects on infant
skin during diaper usage. Higher TEWL values in the non-
The results of the transfer study (Study A) confirm the trans- protected skin represents a more compromised epidermal
fer of an ointment formulation to the skin during normal barrier, which predisposes it to further damage from irritants
diaper wear, and demonstrate that the zinc oxide in this present in urine and faeces. Reports by several investigators
formulation is also delivered to the skin.15 Furthermore, the have shown that differences in TEWL values of as little as
levels of zinc oxide transferred to the skin increased from 50% significantly increase individual susceptibility to skin
single diaper wear (3 h) to multiple diaper wear over 24 h. irritation.16 –18 Additional reports have shown that skin per-
Importantly, the relative proportion of zinc oxide that meability to chemical compounds increases 2– 5 fold as TEWL
transfers from the test diaper correlated with the levels in the values rise by as little as 30–50%, respectively.19,20 Changes in
formulation applied to the diaper. permeability of this magnitude, represent an increase in the

© 2001 European Academy of Dermatology and Venereology JEADV (2001) 15 (Suppl. 1), 5 –11
JDV002.fm Page 10 Friday, August 31, 2001 11:49 AM
10 Baldwin et al.
vulnerability of the skin and hence, in the likelihood of rash and
erythema to be more severe upon exposure to irritants normally
present in the diapered environment. The data presented
show that addition of zinc oxide to a petrolatum formulation
provided a notable improvement in TEWL and skin erythema-
protecting characteristics beyond a petrolatum (without ZnO)
formulation alone. The added benefits of zinc oxide can poten-
tially be enhanced by increasing the total level of formulation
delivered to skin or by increasing the level of zinc oxide in the
formulation.
The results of Study C demonstrate skin benefits to the infant
during normal daily wear. At genital, perianal, leg fold, and
buttock areas, use of the ZnO/Pet-containing diaper was asso-
ciated with a reduction in diaper dermatitis compared with the
levels observed among children in the control group. The
results from use of the ZnO/Pet-based formulation were
superior to previously published data on the petrolatum without
zinc oxide formulation.21 These superior infant results are
further supported by the adult arm data in Study B showing
added benefits for zinc oxide. In general, the diaper dermatitis
profile of children in this study showed oscillations over time.
Even considering this effect, the data showed a sustained
separation in rash severity profiles between the two groups
of children. Moreover, the observation that the reduction
in rash severity persisted over the entire course of the
study indicated that the skin benefits associated with use
of the test diaper are long-lived. Thus, infants using the
test diaper were better able to withstand the challenges nor-
mally encountered within the diaper environment. The results
therefore indicate that the continuous delivery of a ZnO / Pet-
based formulation to the skin by this diaper offers an effective
means to help protect the skin in the diapered area.
An important consideration in the evaluation of the present
results is that the severity of the erythema and rash reactions
presented by the children enrolled in the studies was in the
range of what would be considered mild to moderate irritation,
and not severe diaper dermatitis. Indeed, an important inclu-
sion criterion for enrolment into the studies was that children
should not display reactions of sufficient severity to require
physician intervention or treatment, due to our interest in
avoiding the possible confounding effect of topical therapies
in determining the benefits of this diaper. Thus, our results
should not be interpreted as suggesting that this diaper should
be used in place of more aggressive topical therapies that a phy-
sician would consider to be indicated to resolve severe diaper
dermatitis. Rather, in our view, the importance of the present
findings lies with the benefits this technology can offer in terms
of bolstering the ability of the epidermis to withstand the
irritant insults it normally encounters under the diaper environ-
ment, and thus helping in the prevention of diaper rash. During
the past 10 –15 years, a number of technological innovations in
disposable diaper designs and materials have aimed at reducing
dermatological problems in the diaper area. One of the most
© 2001 European Academy of Dermatology and Venereology JEADV (2001) 15 (Suppl. 1), 5–11
notable advances in reducing skin overhydration was the
introduction of absorbent gelling materials. Clinical study data
and pre- and post-market data on diapers with absorbent gelling
materials have shown reductions in the incidence and severity
of diaper rash in the general population.22 Comparing the
current clinical data with these historical diaper clinical data, show
even stronger benefits to the skin for the Pet/ZnO formulation-
treated diaper than the absorbent gelling materials. The mag-
nitude of improvement in rash severity versus control is larger
for the ZnO/Pet diaper and the population size required to
detect the significant improvement is much smaller for the
ZnO/Pet diaper product.
In conclusion, the studies presented have demonstrated
that the continuous delivery of a zinc oxide / petrolatum-based
formulation via this diaper, brought about improvements in the
condition of the diapered skin compared to high quality con-
ventional diapers. This benefit is enhanced by the addition
of zinc oxide to the petrolatum-based formulation. We antici-
pate that this advance in diaper design will further contribute to
reduce the prevalence and severity of irritant contact dermatitis
in the diaper area. Providing early intervention in the diaper
dermatitis cascade can help to prevent or reduce epidermal
damage before it can compound into more severe reactions
that would require medical intervention and /or treatment.
Acknowledgements
We thank Rachelle Eusebio for statistical analysis of the results.
We also would like to acknowledge Hill Top Laboratories
(Cincinnati, OH, USA and Winnipeg, Canada) for their collab-
oration in the conduct of the clinical studies.
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