Diaper Dermatitis: Appropriate Evaluation ... - ModernMedicine
Diaper Dermatitis: Appropriate Evaluation ... - ModernMedicine
Diaper Dermatitis: Appropriate Evaluation ... - ModernMedicine
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In association with<br />
A p ril 2 0 0 9<br />
<strong>Diaper</strong> <strong>Dermatitis</strong>:<br />
<strong>Appropriate</strong> <strong>Evaluation</strong> &<br />
Optimal Management Strategies<br />
Sponsored by
<strong>Diaper</strong> <strong>Dermatitis</strong> - <strong>Appropriate</strong> <strong>Evaluation</strong><br />
& Optimal Management Strategies<br />
Sheila Fallon Friedlander, Md<br />
Moderator/Chair<br />
Clinical professor of pediatrics and<br />
Medicine (Dermatology)<br />
rady Children’s Hospital, San Diego<br />
University of California, San Diego<br />
Lawrence F. Eichenfield, Md<br />
professor of pediatrics and<br />
Medicine (Dermatology)<br />
Chief, pediatric and Adolescent Dermatology<br />
rady Children’s Hospital, San Diego<br />
University of California, San Diego<br />
April 2009<br />
James Leyden, Md<br />
Emeritus professor of Dermatology<br />
Department of Dermatology<br />
University of pennsylvania<br />
philadelphia, pennsylvania<br />
Jennifer Shu, Md, FAAP<br />
Children’s Medical Group, p.C.<br />
pediatrician and Author<br />
Atlanta, Georgia<br />
Mary c. Spellman, Md<br />
Dermatologist and pharmaceutical<br />
Development Advisor<br />
San Francisco, California<br />
Diane Kebabjian<br />
NATIONAL SALES MANAGER<br />
Steve Farrell<br />
NATIONAL SALES MANAGER<br />
Leonardo Avila<br />
ASSOCIATE PUBLISHER<br />
R. Steve Morris<br />
EXECUTIVE VICE PRESIDENT<br />
Laura Wagner<br />
VICE PRESIDENT,<br />
OPERATIONS & PRIMARY CARE<br />
Peggy K. Onstad<br />
GENERAL MANAGER AND<br />
GROUP PUBLISHER<br />
John C. Marlow, MD<br />
CHIEF MEDICAL AND<br />
COMPLIANCE OFFICER<br />
The views and opinions expressed by the participants of<br />
this supplement do not necessarily reflect the views and<br />
opinions of Contemporary Pediatrics or Medisys Health<br />
Communications Inc.<br />
©2009 Medisys Health Communications, Inc.<br />
E0012z<br />
IntroductIon<br />
Irritant diaper dermatitis (IDD) is a localized form of contact dermatitis<br />
caused by several factors, including warmth, chafing, prolonged contact with<br />
urine and feces, and overhydration of the upper portion of the skin (stratum<br />
corneum). 1 Many experts believe that the presence of Candida yeast infection<br />
also plays a primary, as well as a secondary, role in the development of this<br />
frequently troublesome and sometimes painful eruption. 1 IDD is so common<br />
that infants in the United States have a 1 in 4 chance of being diagnosed with<br />
this condition. 2 In a recent UK study that included the parents of 532 hospitalized<br />
children in diapers, 52% of families reported a history of diaper dermatitis<br />
(DD), and multivariate analysis demonstrated the risk of DD to be<br />
associated with oral thrush, past history of disease, frequency of diaper<br />
changes, and diarrhea. 3 There were 4.8 million outpatient visits for DD from<br />
1990 to 1997; pediatrician visits accounted for 75% of these, and the remaining<br />
25% of visits involved family physicians, internists, dermatologists, and<br />
other specialists. 2 IDD is a therapeutic challenge for both parents and physicians<br />
because of its frequency and the difficulty in eliminating all of the<br />
causative factors in diapered infants.<br />
IDD is generally episodic and relatively self-limiting. It peaks<br />
in frequency at 9 to 12 months of age. 4 However, moderateto-severe<br />
IDD can be more problematic, and is<br />
frequently associated with Candida albicans.<br />
Although estimates of candidiasis-<br />
associated DD vary, early<br />
studies reported recovery of<br />
the organism in 41% to<br />
80% of infants with IDD,<br />
and a positive correlation
has been demonstrated between the clinical severity<br />
of IDD and the presence and level of C albicans in the<br />
diaper, mouth, and anus of infants. 5–8<br />
This panel agrees that IDD often can be managed<br />
effectively in its early stages by keeping the diaper<br />
area dry and the stratum corneum intact. This can<br />
be accomplished with frequent diaper changes, gen-<br />
IDD is so common that infants in the United<br />
States have a 1 in 4 chance of being diagnosed<br />
with this condition.<br />
tle cleansing, and use of barrier protection. In some<br />
cases, mild topical corticosteroids, such as hydrocortisone<br />
1%, may be useful. 9 If IDD worsens or persists<br />
for more than 3 days, candidiasis-associated DD<br />
should be strongly considered as a diagnosis. 10<br />
Candidiasis-associated DD can be severe, and it is<br />
important that the clinician recognize its associated<br />
signs and symptoms so that the rash can be treated<br />
appropriately with an antifungal agent.<br />
Practitioners should be aware that other less<br />
common, but potentially more serious, conditions<br />
can also “masquerade” as DD, including metabolic<br />
and nutritional disorders, malignancies, and a broad<br />
set of primary cutaneous disorders, such as psoriasis.<br />
11 These conditions should be considered as diagnoses,<br />
particularly if a patient does not respond<br />
to appropriate therapy.<br />
Prescribing patterns for moderate-to-severe DD<br />
demonstrate that topical antifungal agents, mid- to<br />
high-potency steroids, and combinations of both are<br />
often prescribed despite the fact that higher potency<br />
steroids may not be the best choice for use on the<br />
delicate, generally occluded diaper area of infants. 2<br />
B e c a u s e o f h i g h r a t e s o f c a n d i d a l<br />
colonization and infection associated with DD, patients<br />
may benefit from the use of a topical antifungal<br />
agent in addition to the traditional approaches for the<br />
treatment of persistent DD (appropriate cleansing<br />
and the use of barrier agents). A topical antifungal<br />
agent such as miconazole can be used for this purpose<br />
in conjunction with barrier products to protect the<br />
skin. A combination barrier antifungal ointment containing<br />
miconazole nitrate 0.25%, zinc oxide 15%,<br />
and white petrolatum 81.35% received FDA approval<br />
in February 2006 for the treatment of candidiasisassociated<br />
DD for pediatric patients aged ≥4 weeks. 12<br />
It is an alternative agent that provides a consolidated<br />
and simplified therapy for patients diagnosed with<br />
DD where secondary Candida involvement is likely.<br />
In severe cases of candidiasis-associated DD that is<br />
unresponsive to topical agents, oral agents such as<br />
nystatin may be useful in minimizing Candida species<br />
in the gastrointestinal (GI) tract, the primary<br />
reservoir of Candida spp.<br />
FActorS InvoLvEd In thE<br />
dEvELoPMEnt oF dIAPEr dErMAtItIS<br />
<strong>Diaper</strong> dermatitis arises from the interaction of several<br />
factors, the most important of which is prolonged<br />
contact of the skin with a mixture of urine<br />
and feces. The combination of diaper occlusion, fecal<br />
enzyme activity, urine, and diaper chafing leads<br />
to overhydration of the stratum corneum and chemical<br />
and mechanical abrasion, which compromises<br />
barrier function and makes the stratum corneum<br />
more susceptible to frictional trauma and the penetration<br />
of irritants and microbes. Hydrated skin is<br />
more likely to suffer frictional damage than dry skin,<br />
and frictional alterations in skin barrier function induced<br />
by overhydration can then subsequently<br />
change the balance of resident flora and promote<br />
growth and likely the invasiveness of C albicans,<br />
which is found in as many as 70% of infants<br />
with DD. 13,14<br />
Role of Urine And Feces<br />
Although urinary ammonia was traditionally<br />
thought to be an important etiologic factor<br />
in the development of IDD, a small study<br />
found no difference in the mean level of ammonia<br />
in the morning diaper obtained from<br />
26 infants with IDD compared with the mean<br />
level obtained from 82 control patients. 15 Furthermore,<br />
the experimental application of highly ammoniacal<br />
urine on intact infant and adult skin did not<br />
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elicit a dermatologic reaction. Erythema could be<br />
induced when ammoniacal urine was applied to skin<br />
that had been scratched sufficiently enough to compromise<br />
the skin barrier. In addition to the capacity<br />
of urine to irritate damaged skin, its most important<br />
role in the development of IDD is its proclivity for<br />
skin hydration. Thus, urinary ammonia on intact<br />
skin without secondary contamination does not appear<br />
to be a primary etiologic factor in IDD. 15<br />
However, the interaction of urine and feces is fundamental<br />
in the development of IDD. Berg and colleagues<br />
demonstrated that bacterial ureases in the<br />
stool degrade urea in urine, which releases ammonia;<br />
however, ammonia does not actually irritate the skin,<br />
but rather mediates irritation by increasing local pH. 16<br />
Increased pH reactivates fecal enzymes such as lipase<br />
and protease, which irritate the skin and disrupt the<br />
epidermal barrier. 16 It has also been demonstrated<br />
that the incidence and severity of IDD is significantly<br />
higher in infants with a 48-hour history of diarrhea.<br />
10,17 While it has been suggested that this higher<br />
rate of IDD could be due to increased exposure of the<br />
skin to irritation from fecal enzymes, it may be possible<br />
that additional moisture present in diarrhea<br />
versus normal stool could contribute to the increased<br />
incidence and severity of IDD in patients with loose<br />
stools. 17 Supporting this theory is the demonstration<br />
that skin wetness strongly correlates with both the<br />
risk and severity of IDD. 18 It is feasible that the excess<br />
moisture that accompanies diarrhea hydrates the<br />
skin, and when occluded, this increased hydration<br />
causes the skin barrier to further deteriorate. Thus,<br />
irritation may be enhanced by excess moisture in<br />
diarrheal stool, as well as the increased amount of<br />
fecal proteases and lipases in contact with the diaper<br />
area during bouts of diarrhea. 19<br />
cAndIdIASIS-ASSocIAtEd<br />
dIAPEr dErMAtItIS<br />
The cutaneous bacterial flora of the diaper area are<br />
abundant, regardless of the underlying condition of<br />
the skin. 6 Various organisms, including Staphylococcus<br />
aureus, Escherichia coli, and Proteus, have been recovered<br />
from the skin of infants with IDD, although<br />
these organisms are not considered causative. 6 C albicans,<br />
in contrast, has been widely implicated in<br />
moderate-to-severe DD. 7<br />
Candida is a genus of yeast-like fungi that is often<br />
part of the flora of the skin, mouth, and GI tract of<br />
infants. Excessive growth of Candida appears to<br />
increase the likelihood of invasive disease. Colonization<br />
by Candida spp appears to be significantly more<br />
frequent in children with IDD than in healthy controls.<br />
In a study by Ferrazzini et al, researchers compared<br />
the rates of colonization at 3 body sites in<br />
children with IDD and healthy controls. 8 The results<br />
demonstrated greater rates of colonization at<br />
all sites among the affected children versus the<br />
healthy controls: perianal, 75% vs 19%; inguinal,<br />
50% vs 10%; and oral, 68% vs 25%. 8 The same study<br />
also demonstrated a highly significant, positive correlation<br />
between the extent of Candida spp coloniza-
tion at all swab locations and disease severity. The<br />
researchers noted that relatively limited microbial<br />
colonization in the area of rash at the inguinal folds<br />
may not be relevant to disease severity, although<br />
extensive colonization is associated with disease<br />
exacerbation. 8<br />
Primary and Secondary Candida Infection<br />
The observation of relatively low levels of C albicans<br />
at some rash sites underscores the challenge<br />
in determining whether Candida is a causative factor<br />
in candidiasis-associated DD or if it is a secondary<br />
contaminant that flourishes in the moist,<br />
warm environment of the diaper area and then<br />
capitalizes on the disrupted skin barrier of the<br />
diaper environment.<br />
In support of the latter statement that Candida is<br />
a secondary contaminant, one study suggests that if<br />
sufficient moisture is present, adequate nutrients for<br />
the growth of C albicans exist on human skin. 20 In<br />
another study, Candida spp were identified in the<br />
diaper area of children who had healthy skin, which<br />
demonstrated that this area can be populated by<br />
Candida spp to a small degree without causing symptoms.<br />
8 In a study that used an experimental human<br />
infection model of erosio interdigitalis blastomycetica,<br />
it was demonstrated that recovery of C albicans<br />
decreased once the organism established itself on the<br />
skin and intense inflammation developed. 21 C albicans<br />
appears to be the initial contaminant, but infection<br />
was attributed to synergism of the organism with<br />
gram-negative rods, a synergy that might reproduce<br />
itself similarly with resident flora in candidiasis-<br />
associated DD. Once inflammation was present, the<br />
recovery of the organism decreased. 22<br />
Other observations support a primary role for<br />
Candida in the development of DD. It has been demonstrated<br />
that Candida does not require clinically<br />
inflamed skin to proliferate and cause infection.<br />
C albicans infection requires only moist occlusion on<br />
normal skin to grow. However, without moisture and<br />
occlusion, C albicans cannot compete against resident<br />
microflora. 21,22<br />
These studies illustrate that in a moist environment,<br />
Candida can colonize multiple areas on its<br />
own—even in a highly functional stratum corneum,<br />
and suggest that failure to recover the organism does<br />
not preclude the possibility of prior C albicans involvement.<br />
Although it is likely that an impaired stratum<br />
corneum is vulnerable to secondary colonization,<br />
a compromised skin barrier does not appear to<br />
be a prerequisite for colonization. It would seem that<br />
failure to consistently recover C albicans in clinically<br />
infected skin has been emphasized in the literature<br />
too heavily, and the colonization characteristics of<br />
C albicans too seldom. The data provide supportive<br />
evidence for both the primary and secondary contamination<br />
of C albicans in the diaper area.<br />
Candida and the Gastrointestinal Tract<br />
The consistently higher rate of recovery of C albicans<br />
from the GI tract relative to the rash site supports<br />
the GI tract as a reservoir for C albicans, with<br />
infection resulting from the spread of the organism<br />
onto the diaper area. There is a strong correlation<br />
between the level of C albicans in the feces and disease<br />
severity. 4,23 In a study assessing 30 infants with<br />
candidiasis-associated DD, the authors recovered<br />
C albicans from satellite pustules in all 30 infants,<br />
from the central area of erythema in 66% of patients,<br />
and from the rectum in 93% of infants. 23<br />
Candida and Antibiotic Use<br />
Clinical situations promoting C albicans growth in the<br />
GI tract presumably increase the risk of candidiasisassociated<br />
DD. In a study quantifying C albicans<br />
colonization before and after antibiotic therapy, a<br />
10-day course of systemic antibiotics administered<br />
to infants with otitis media who were otherwise<br />
healthy was associated with a 2-fold increase in<br />
C albicans recovery from the rectum and skin. 24<br />
Furthermore, the infants who developed IDD had<br />
significantly greater numbers of C albicans organisms<br />
recovered from these sites. The presence of<br />
thrush also is an important diagnostic clue in the<br />
evaluation of an infant with DD. 25 Thrush is highly<br />
correlated with GI colonization, and it has been<br />
demonstrated that 52% of infants with oral candidiasis<br />
develop candidiasis-associated DD. 25<br />
These studies demonstrate that candidiasis-<br />
associated DD is linked to predisposing factors including<br />
diarrhea, antibiotic exposure, and/or the<br />
presence of thrush, but can also present as primary<br />
disease. Candidiasis should be suspected in any<br />
case of IDD that lasts more than 3 days. 10 Potassium<br />
hydroxide (KOH) preparation and fungal culture<br />
should be collected from satellite lesions/satellite<br />
papules and pustules rather than the central area of<br />
rash, and though recovery of C albicans from the<br />
skin can be challenging, the GI tract usually manifests<br />
heavy growth. In the case of persistent dermatitis<br />
with a low yield from KOH and culture, the best<br />
chance of recovering C albicans is with a rectal swab.<br />
It is important that candidiasis-associated DD is<br />
treated immediately; clinicians should use their<br />
judgment in the case of a negative KOH and con-<br />
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<strong>Diaper</strong> <strong>Dermatitis</strong> | <strong>Appropriate</strong> <strong>Evaluation</strong> & Optimal Management Strategies<br />
April 2009<br />
sider treating with an antifungal agent if candidiasis<br />
is suspected clinically.<br />
dIFFErEntIAL dIAGnoSIS<br />
oF dIAPEr dErMAtoSES<br />
The diagnosis of diaper dermatoses is usually straightforward,<br />
but occasionally rarer, more serious disorders<br />
can “masquerade” as DD. Therefore, it is important<br />
to always consider other diagnoses, particularly if a<br />
patient does not respond to appropriate therapy for<br />
Diagnostic and Treatment Guide for IDD and Candidiasis-Associated DD<br />
Confluent erythematous papules<br />
Scaling<br />
Skin folds spared<br />
IDD<br />
Treatment<br />
Frequent diaper changes<br />
Gentle cleansing Barrier cream<br />
Insufficient response<br />
Rash >3 days<br />
Inflammation<br />
Patient History<br />
Topical antifungal or Vusion plus<br />
Short course of low potency topical corticosteroid<br />
No response – evaluate for other diagnosis<br />
Rash >3 days<br />
Irregular, scaly border<br />
Satellite lesions<br />
Skin folds involved<br />
Candidiasis-Associated DD<br />
Treatment<br />
Topical antifungal or<br />
Vusion<br />
Insufficient response<br />
Inflammation<br />
Add short course of<br />
low-potency topical corticosteroid<br />
FIGurE 1. Diagnostic and Treatment Guide for iDD and<br />
Candidiasis-Associated DD<br />
DD (Figure 1). Table 1 26 provides a comprehensive<br />
list of differential diagnoses, the important features of<br />
which are discussed in more detail below.<br />
IDD, the most common form of DD, presents<br />
with confluent erythema and papules (Figure 1). Severe<br />
cases may also exhibit areas of erosion. This<br />
dermatitis is usually localized to convex areas in contact<br />
with the diaper, including the buttocks, medial<br />
thighs, mons pubis, scrotum, and labia majora. IDD<br />
FIGurE 2. irritant <strong>Diaper</strong> <strong>Dermatitis</strong>. iDD showing<br />
sparing of the skin folds. Photograph courtesy of Baby411.com<br />
tAbLE 1. Differential Diagnosis for Eruptions<br />
in the <strong>Diaper</strong> Area<br />
Inflammatory<br />
irritant contact dermatitis<br />
Allergic contact dermatitis<br />
intertrigo<br />
Seborrheic dermatitis<br />
Atopic dermatitis<br />
psoriasis<br />
Jacquet’s dermatitis<br />
Granuloma gluteale infantum<br />
perianal pseudoverrucous papules and nodules<br />
Infectious<br />
Candidiasis<br />
Folliculitis<br />
Bullous impetigo<br />
perianal/intertriginous streptococcal disease<br />
Herpes simplex<br />
Scabies<br />
Congenital syphilis<br />
Nutritional/Metabolic<br />
Acrodermatitis enteropathica<br />
Biotin deficiency<br />
Kwashiorkor secondary to malabsorption/starvation<br />
Cystic fibrosis<br />
Malignancy<br />
langerhans’ cell histiocytosis<br />
Miscellaneous<br />
Miliaria<br />
Child abuse<br />
Source: Ref 33<br />
is often accompanied by perianal erythema, but the<br />
most distinctive feature of IDD is sparing of the skin<br />
folds (Figure 2).<br />
Tidewater-mark, Lucky Luke, and diaper-dye<br />
dermatoses are variants of contact dermatitis, and<br />
each has recognizable patterns to differentiate them<br />
from uncomplicated IDD.<br />
<strong>Diaper</strong>-dye dermatitis can be distinguished by<br />
its well-demarcated erythematous papules at the<br />
colored edges of the diaper. There may be crossover<br />
between this and tidewater-mark dermatitis, which<br />
presents as band-like erythema on the thighs and<br />
abdomen at the diaper edges, sparing the skin folds.<br />
Lucky Luke DD also has an easily recognizable<br />
pattern that resembles a cowboy’s gunbelt holster<br />
and is located on the outer buttocks and hips (Figure<br />
3a); it develops in response to rubber components<br />
in the diaper. Because of the potential for<br />
contact dermatitis, parents should be cautioned to<br />
avoid products with additives that are known to<br />
cause a reaction in their child.<br />
Both Jacquet’s dermatitis and granuloma gluteale
FIGurE 3A. lucky luke <strong>Dermatitis</strong><br />
Photograph courtesy of Victoria Barrio, MD<br />
FIGurE 3c. Severe Candida infection<br />
Photograph courtesy of Sheila Fallon Friedlander, MD<br />
infantum are severe variants of IDD. Jacquet’s dermatitis<br />
presents with easily recognizable, punchedout<br />
ulcered papules and is usually associated with<br />
infrequent diaper changes. However, it has become<br />
increasingly rare with the advent of super-absorbent<br />
diapers. 27 Granuloma gluteale infantum can be distinguished<br />
from uncomplicated IDD by its asymptomatic<br />
violaceous papules and nodules on prominent<br />
areas of the groin, abdomen, genitalia, and thighs.<br />
Potential risk factors include a history of topical corticosteroid<br />
use, Candida infection, or use of occlusive<br />
plastic diaper covers. 26<br />
Candidiasis-associated DD consists of bright red,<br />
confluent areas of involvement with irregular, scaly<br />
border and papulopustular satellite lesions. The intertriginous<br />
areas are involved, which distinguishes it<br />
from uncomplicated IDD. Figures 3b and 3c illustrate<br />
presentations of candidiasis-associated DD.<br />
Candidiasis-associated DD is also differentiated from<br />
FIGurE 3b. Candida <strong>Diaper</strong> <strong>Dermatitis</strong> infection. (Note the intertriginous<br />
erythema and superimposed papules.) Photograph courtesy of Sheila Fallon Friedlander, MD<br />
FIGurE 4. Streptococcal intertrigo. (Note moist, red,<br />
eroded areas) Photograph courtesy of Sheila Fallon Friedlander, MD<br />
IDD by a rash duration >3 days (Figure 1). Many<br />
patients may have a history of recent diarrhea, concomitant<br />
oral thrush, or antibiotic exposure.<br />
Seborrheic dermatitis presents as salmon-colored,<br />
well-demarcated scaling plaques, especially at the inguinal<br />
folds. It can also be associated with candidiasisassociated<br />
DD, but it is often distinguished by the<br />
presence of greasy, scaling lesions elsewhere on the<br />
body, especially on the scalp, face, postauricular<br />
folds, neck, and axilla. 8 Seborrheic dermatitis usually<br />
appears by 3 to 4 weeks of age and often resolves<br />
spontaneously by 3 to 4 months of age.<br />
Intertrigo presents as moist and sharply demarcated<br />
erythema at the skin folds with minimal scale<br />
and can be distinguished from candidal infection<br />
by a lack of satellite lesions. Intertrigo is a superficial<br />
inflammatory process on skin surfaces in close opposition<br />
with one another arising from a combination<br />
of moisture, heat, sweat retention, and friction.<br />
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FIGurE 5. Bullous impetigo of the <strong>Diaper</strong> Area.<br />
(Note erosions and pustules.) Photograph courtesy of Sheila Fallon<br />
Friedlander, MD<br />
Secondary streptococcal infection can develop in<br />
the intertriginous folds of the diaper area (Figure<br />
4), as well as the neck and axillae. This infection is<br />
associated with a bright red and moist appearance<br />
with sharply demarcated borders. Bullous impetigo<br />
(Figure 5) can also develop in the diaper area, and<br />
may occasionally be mistaken for candidiasis-<br />
associated DD. S aureus folliculitis superimposed<br />
on IDD (Figure 6) is another bacterial infection<br />
that can involve the diaper area, and must be recognized<br />
so that appropriate antibiotic therapy can<br />
be instituted. This disorder can sometimes be confused<br />
with the more common candidiasis-associated<br />
dermatitis, but KOH and culture evaluation will<br />
distinguish between the two. Severe deep-seated<br />
bacterial infections, including furunculosis, and<br />
severe life-threatening infections such as Fournier’s<br />
gangrene can develop if the bacterial etiology of<br />
the skin findings is not recognized and treated<br />
appropriately. 28<br />
Atopic dermatitis presents as mild erythema and<br />
scaling, and can occasionally involve weeping crusted<br />
lesions. 8 Atopic dermatitis is usually associated with<br />
concurrent or previous flares of rash on the face and<br />
extensor limbs, and though it usually spares the diaper<br />
area, it can sometimes resemble IDD or seborrheic<br />
dermatitis. 8 Diagnosis is often based on a positive<br />
personal or family history of allergic rhinitis, hay<br />
fever, or asthma. In the differential diagnosis, concurrent<br />
or previous rash elsewhere on the body is its<br />
primary feature. 8<br />
Unfortunately, other more serious disorders can<br />
sometimes initially be mistaken for DD. Langerhans’<br />
cell histiocytosis (LCH) is a rare and potentially lifethreatening<br />
condition caused by bone marrow-<br />
derived cells that are dendritic in nature and can ac-<br />
cumulate in other organs, including the skin. 11 LCH<br />
can present as either single, few, or disseminated erythematous<br />
papules, vesiculopustules, and/or<br />
petechiae. Erosions and/or ulcerations in the groin,<br />
scale, and crusting can appear either alone or in<br />
combination. 11 Scaly, red-brown or purpuric papules<br />
may appear on the trunk, which are more violaceous<br />
than seborrheic dermatitis (Figures 7 and 8). An extensive<br />
eruption may resemble severe candidiasis;<br />
however, violaceous papules near the umbilicus are<br />
typical of LCH. A biopsy must be obtained when this<br />
diagnosis is suspected. 11<br />
Other serious disorders include metabolic and<br />
nutritional deficiencies, including acquired or con-<br />
FIGurE 6. Staphyloccoccal Folliculitis Superimposed<br />
on irritant <strong>Diaper</strong> <strong>Dermatitis</strong>. (Note discrete follicular<br />
papules and pustules scattered over the buttocks<br />
area.) KOH and culture will distinguish between this<br />
disorder and the more common Candida diaper<br />
dermatitis. Photograph courtesy of Sheila Fallon Friedlander, MD<br />
FIGurE 7. langerhans’ Cell Histiocytosis. (Note the<br />
intertriginous involvement, erosions and purpuric<br />
papules.) Photograph courtesy of Victoria Barrio, MD
genital zinc defects. 11 Acrodermatitis enteropathica<br />
(Figure 9) is a congenital disorder in which there is a<br />
defect in zinc absorption from the gut. 11 Breast milk<br />
zinc deficiency can occur when maternal breast milk<br />
does not have sufficient zinc. 11 Affected children<br />
quickly recover from the latter disease when supplements<br />
are provided. 11 In contrast, children with<br />
classic acrodermatitis enteropathica may require<br />
significant zinc supplementation for life. 11 In these<br />
disorders, extensive refractory disease usually develops<br />
and involves the perioral, genital, and acral<br />
areas. 11 Erythema and peeling of the skin on the<br />
hands and feet, as well as paronychial changes of<br />
the nail may occur. 11<br />
One distinct subset of DD may occasionally be a<br />
harbinger of future psoriatic disease. 11 Napkin psoriasis<br />
presents as sharply demarcated erythematous<br />
plaques, especially at the inguinal folds and on the<br />
scrotum or convex areas. There is scaling, but this<br />
can be difficult to discern due to the moisture of the<br />
area. The initial lesion usually develops in the intertriginous<br />
groin area, followed by a secondary dermatitis<br />
that resembles psoriasis. 29 Involvement of the<br />
umbilical area is a clue to this diagnosis. Napkin psoriasis<br />
is due to koebnerization, and may resolve once<br />
the infant is toilet trained; however, a strong correlation<br />
between the appearance of psoriasis in infancy<br />
and later in life has been demonstrated. 30<br />
Distinguishing one form of DD from another can<br />
be challenging, but an accurate diagnosis can be<br />
made if the clinician concentrates on the location and<br />
morphology of the rash, particularly regarding involvement<br />
or lack of involvement of the skin folds or<br />
other sites on the body such as the scalp and umbilicus.<br />
The presence of papules, purpura, or petechiae is an<br />
important clue, as is the response to traditional barrier<br />
therapy with antifungal therapy added as appropriate.<br />
If a patient does not improve with such measures,<br />
less common but potentially more serious<br />
disorders should be considered.<br />
MAnAGEMEnt oF Idd<br />
The treatment of uncomplicated IDD is outlined in<br />
Figure 1. Educating caregivers about an optimal diapering<br />
routine is crucial to successful treatment. Extensive<br />
clinical practice has long supported a stepwise<br />
approach to the treatment of DD that includes a combination<br />
of frequent diaper changes, gentle cleansing,<br />
barrier protection, and antifungal/anti-inflammatory<br />
treatment (if the eruption lasts more than a few days)<br />
(Figure 1). First, it is important to emphasize prevention,<br />
and the most effective prevention is to ensure<br />
that the infant’s skin stays clean and dry.<br />
FIGurE 8. langerhans’ Cell Histiocytosis.<br />
Photograph courtesy of Victoria Barrio, MD<br />
FIGurE 9. Zinc Deficiency. (Note severe confluent<br />
erosions and scale.) This child did not respond to<br />
routine diaper dermatitis therapy, and developed<br />
periorificial and acral (fingers and toes) lesions.<br />
Photograph courtesy of Lawrence F. Eichenfield, MD<br />
Improved <strong>Diaper</strong> Technology<br />
It has been estimated that disposable diapers account<br />
for more than 90% of diapers used in developed<br />
nations. 31 <strong>Diaper</strong> technology has improved significantly<br />
over the last few decades and continues to<br />
evolve. Disposable diapers that contain superabsorbent<br />
gelling materials are associated with a reduced<br />
incidence and decreased severity of IDD. 4,31 Although<br />
studies have reached various conclusions<br />
regarding the benefits of disposable diapers over<br />
cloth diapers, it is intuitive that diapers with the<br />
capacity for maintaining normal skin pH and hydration<br />
are important in the prevention and treatment<br />
of DD. 4,13,32 One study demonstrated that infants<br />
diapered exclusively in disposable diapers developed<br />
less rash than those diapered exclusively or occa-<br />
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10 April 2009<br />
sionally in cloth diapers. 4<br />
Further innovations include a disposable diaper<br />
that provides continuous topical administration of a<br />
zinc oxide/petrolatum formulation. Use of this diaper<br />
is associated with improvements in erythema and<br />
diaper rash in patients with mild-to-moderate IDD. 33<br />
A helpful component in the treatment of moderate-tosevere<br />
candidiasis-associated DD is ensuring the use<br />
of a breathable diaper. Highly breathable diapers have<br />
been associated with a 38% to 50% reduction in severe<br />
IDD cases among infant patients, including those with<br />
confirmed candidiasis. 26 In a study involving adult<br />
volunteers, it was demonstrated that when C albicans<br />
cells were occluded with a patch from either a highly<br />
breathable diaper or a standard diaper on the volar<br />
forearm, Candida colonization was observed nearly<br />
two-thirds less in the highly breathable diaper-covered<br />
sites compared to the control sites. 26<br />
Cleansing<br />
Excessive washing of the diaper area should be<br />
avoided as a preventive and treatment approach for<br />
DD. Once the diaper is soiled, the feces should be<br />
removed from the skin as soon as possible with water<br />
and a soft cloth. If a barrier preparation has been<br />
used, the caregiver should focus on removing the<br />
stool from the barrier product rather than completely<br />
removing the barrier. Then an additional<br />
layer of cream or ointment should be applied to the<br />
remaining barrier preparation. Parents who work to<br />
remove all the ointment often induce more trauma<br />
and irritation at the site. 11 The use of baby wipes<br />
minimizes the risk of frictional injury. Baby wipes<br />
that contain alcohol should be avoided because some<br />
types of alcohol can be drying; however, most baby<br />
wipes are alcohol-free and contain 98% water. 11 pHbuffered<br />
baby wipes and products formulated for<br />
sensitive skin have minimized the likelihood of irritancy<br />
from these products. 34<br />
If the caregiver needs to wash the diaper area<br />
more thoroughly, a nonirritating cleanser such as<br />
Cetaphil ® (Galderma Laboratories) or mineral oil<br />
can be used. Many practitioners use cotton swabs or<br />
pads to apply the cleanser. Cloth or pressed cotton<br />
cosmetic pads are less likely to adhere to the skin<br />
surface and break apart, and are more effective for<br />
removing feces.<br />
Treatment Options for Irritant<br />
<strong>Diaper</strong> <strong>Dermatitis</strong><br />
The management of all diaper dermatoses should<br />
include reducing moisture in the diaper area, minimizing<br />
contact with urine and feces, and eradicating<br />
infectious organisms (Figure 1). With the exception<br />
of candidiasis-associated DD, IDD is episodic and<br />
tends to be relatively self-limiting in nature if the offending<br />
irritants are removed. Occasionally, patients<br />
may have a true allergic contact dermatitis, in which<br />
case it is important to eliminate the causative agent,<br />
Baby wipes that contain alcohol should be<br />
avoided because some types of alcohol can be<br />
drying; however, most baby wipes are<br />
alcohol-free and contain 98% water.<br />
which may be present as a coloring additive or elastic/<br />
rubber agent in the diaper.<br />
Numerous over-the-counter (OTC) barrier formulations<br />
are available. Table 2 lists some of the more commonly<br />
used products and their active ingredients. 35<br />
Petrolatum is a safe and effective OTC barrier product<br />
that protects the skin, reduces transepidermal<br />
water loss, and repels water. Petrolatum provides a<br />
thick, protective barrier and is useful in the prevention<br />
of IDD. It is also a commonly used ingredient in<br />
other OTC barrier products such as Vitamin A & D ®<br />
Ointment (Schering-Plough Healthcare) and in pre-
scription products such as Vusion ® Ointment (Barrier<br />
Therapeutics). Lanolin is another effective skin<br />
protectant that also is used in Vitamin A & D Ointment<br />
and other skin lotions and creams. Many infants<br />
will benefit from traditional lanolin-containing therapies;<br />
however, the healthcare provider must be<br />
aware that in children who are allergic to lanolin,<br />
such products may aggravate the condition.<br />
Zinc oxide preparations such as Desitin ® (Johnson<br />
& Johnson) are available in 10% and 40% ointment<br />
formulations (Table 2). For treatment of uncomplicated<br />
IDD, a petrolatum product, Vitamin A & D<br />
Ointment, or a product containing 10% zinc oxide<br />
may be sufficient. For moderate-to-severe IDD, a<br />
barrier ointment with a greater concentration of<br />
zinc oxide can also be used. Zinc oxide pastes are<br />
highly effective barriers, but they are difficult to<br />
wash off, and aggressive cleansing of the skin when<br />
removing a paste is very irritating. Mineral oil is<br />
more effective than soap and water to remove a<br />
paste. A thin layer of petrolatum can be applied to<br />
the paste to prevent opposing skin surfaces from<br />
sticking together and to ensure that the paste does<br />
tAbLE 2. Commonly Used Barrier preparations and Their Active ingredients<br />
not adhere to the diaper.<br />
The use of cornstarch is recommended over<br />
talcum powder to reduce frictional injury, especially<br />
if the caregiver uses cloth diapers. Although it has<br />
been suggested that powders and cornstarch enhance<br />
microbial growth, in a study by Leyden it was demonstrated<br />
that neither product is associated with proliferation<br />
of C albicans. 20 The use of talcum powder<br />
has been associated with severe respiratory distress<br />
caused by accidental inhalation. 36,37<br />
Treatment of Candidiasis-Associated<br />
<strong>Diaper</strong> <strong>Dermatitis</strong><br />
In 2006, Vusion, the first antifungal agent indicated<br />
for the treatment of candidiasis-associated DD became<br />
available. This combination barrier-antifungal<br />
Barrier Active ingredient(s)<br />
Vitamin A&D ointment ® Vitamin A, vitamin D, lanolin, white petrolatum, paraffin<br />
A&D diaper rash cream with zinc oxide and aloe ® Zinc oxide (10%), dimethicone (1%)<br />
Aquaphor ® petrolatum, lanolin<br />
Aveeno diaper cream ® Zinc oxide (13%), dimethicone (5%)<br />
Balmex diaper rash ointment ® Zinc oxide (11.3%)<br />
Balmex daily protective clear ointment ® White petrolatum (51.1%)<br />
Balmex creamy lotion barrier ® Zinc oxide (13%)<br />
Boudreaux’s butt paste ® Zinc oxide (16%)<br />
Burt’s bees baby bee, diaper ointment with vitamin A and vitamin E ® Zinc oxide<br />
California baby diaper rash cream ® Zinc oxide (12%), lanolin<br />
Desitin diaper rash ointment, creamy ® Zinc oxide (10%)<br />
Desitin diaper rash ointment, original ® Zinc oxide (40%)<br />
Gerber diaper rash ointment with oatmeal soothers ® Zinc oxide (40%), petrolatum (33%)<br />
Johnson’s baby diaper rash cream with zinc oxide ® Zinc oxide (13%)<br />
Mustela bebe vitamin barrier cream ® Zinc oxide (10%)<br />
palmer’s diaper rash cream, cocoa butter formula ® petrolatum (30%), dimethicone (1%)<br />
Triple paste ® petrolatum<br />
Vaseline ® petrolatum<br />
Vaseline baby, baby fresh scent ® petrolatum<br />
Zinc oxide pastes are highly effective barriers,<br />
but they are difficult to wash off, and aggressive<br />
cleansing of the skin when removing a paste<br />
is very irritating.<br />
Weleda diaper care ® Zinc oxide (12%)<br />
Zinc oxide ointment Zinc oxide (20%)<br />
Source: Ref 33<br />
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1 April 2009<br />
product is an efficient means of treating candidiasisassociated<br />
DD. Until 2006, management consisted<br />
of off-label use of an antifungal agent unapproved<br />
for candidiasis-associated DD or a combination<br />
antifungal/corticosteroid topical product. Some<br />
practitioners still prescribe these and other medicat<br />
i o n s o f f - l a b e l t o t r e a t c a n d i d i a s i s -<br />
associated DD.<br />
The Risks of Mid- to High-Potency Steroids<br />
The use of a mid- to high-potency corticosteroid is<br />
a relatively common, and sometimes hazardous,<br />
practice for the treatment of pediatric dermatoses.<br />
Use of such agents in infants and children, particularly<br />
in occluded areas, can lead to a number of complications,<br />
including atrophy, striae, and adrenal<br />
axis suppression. Unfortunately, caregivers are not<br />
always aware of these risks, and clinicians may need<br />
further education.<br />
Until recently, clinicians had a limited choice<br />
of antifungal and antifungal/corticosteroid<br />
products in their armamentarium, none of<br />
which were formulated specifically to treat<br />
candidiasis-associated DD.<br />
Mid- to high-potency corticosteroids are generally<br />
contraindicated for use in intertriginous and occluded<br />
areas of the skin, especially in infants, as their<br />
use has the potential to cause a variety of adverse<br />
events including systemic absorption, skin atrophy,<br />
striae, tachyphylaxis, and growth delay. Furthermore,<br />
the abraded skin of the diaper area of an infant<br />
with IDD leads to an enhanced rate of percutaneous<br />
absorption of a topical agent, which is further increased<br />
by the occlusiveness of the diaper. 27,38 The<br />
risks of corticosteroid use in infants need to be communicated<br />
to clinicians, and safer therapeutic alternatives<br />
need to be developed.<br />
Commonly Used Antifungal Agents for<br />
Candidiasis-Associated <strong>Diaper</strong> <strong>Dermatitis</strong><br />
Few well-designed comparator trials have assessed<br />
the efficacy of antifungal agents for the treatment of<br />
candidiasis-associated DD. Imidazole antifungal<br />
agents (eg, miconazole, econazole, ketoconazole),<br />
have varying fungicidal activity against cutaneous<br />
Candida spp. 38 Topical azoles are also well-tolerated.<br />
Side effects sometimes seen with systemic azole<br />
therapy are not associated with topical use of these<br />
types of drugs. 38<br />
If an infant has a rash secondary to antibiotic use<br />
and the infant must continue antibiotic therapy, a<br />
thick petrolatum ointment barrier may provide optimal<br />
protection. The practitioner also must consider<br />
the possibility of another diagnosis in patients who do<br />
not respond to appropriate treatment of candidiasisassociated<br />
DD.<br />
Until recently, clinicians had a limited choice of<br />
antifungal and antifungal/corticosteroid products<br />
in their armamentarium, none of which were formulated<br />
specifically to treat candidiasis-associated<br />
DD. Management considerations have been simplified<br />
for the clinician with the FDA approval of Vusion<br />
Ointment (miconazole nitrate 0.25%/zinc oxide<br />
15%/petrolatum 81.35%), which is a safe, effective,<br />
and convenient treatment option for candidiasis-<br />
associated DD. 12<br />
Vusion Ointment (miconazole nitrate 0.25%/<br />
zinc oxide 15%/petrolatum 81.35%)<br />
Vusion Ointment is indicated for the treatment of<br />
candidiasis-associated DD and approved for use in<br />
immunocompetent pediatric patients aged 4 weeks<br />
and older with microscopic evidence of pseudohyphae<br />
and/or budding yeast. 12 Before prescribing<br />
Vusion Ointment, the role of the clinician is to ensure<br />
that the correct diagnosis is made, which includes<br />
considering the more uncommon causes of<br />
IDD and performing ancillary tests (eg, KOH), to<br />
confirm diagnosis if doubt exists as to the etiology<br />
of the eruption.
Vusion Ointment is formulated with a low concentration<br />
(0.25%) of miconazole, which limits<br />
exposure to the antifungal component. The level of<br />
systemic absorption is lower with 0.25% miconazole<br />
than with 2% miconazole cream. 39 Infant skin, as<br />
opposed to adult skin, can absorb a greater proportion<br />
of topical medication because infants have a<br />
greater surface-to-body weight ratio. 40,41 Thus, a<br />
lower concentration formulation of miconazole can<br />
provide effective antifungal activity on infant skin<br />
while theoretically decreasing the risk of extensive<br />
absorption of miconazole. Furthermore, the combination<br />
of miconazole and zinc oxide is synergistic;<br />
zinc oxide also has anti-Candida effects, which potentiates<br />
the antifungal activity of miconazole. 42<br />
Clinical Studies with Vusion Ointment<br />
The efficacy and tolerability of Vusion Ointment<br />
in the treatment of candidiasis-associated DD have<br />
been established in a double-blind, randomized,<br />
multicenter, vehicle-controlled study of 0.25%<br />
miconazole nitrate ointment. 41 The study included<br />
330 patients with an IDD average severity grade ≥3<br />
as assessed by the <strong>Diaper</strong> <strong>Dermatitis</strong> Severity<br />
Score, including a severity grade of ≥2 for erythema.<br />
Patients with a positive KOH preparation and positive<br />
culture of Candida (n=236) composed the<br />
modified intent-to-treat (MITT) group, on which<br />
efficacy analyses were based. Patients were randomized<br />
to receive active treatment or vehicle for 7<br />
days at every diaper change and after bathing. The<br />
primary end point of overall cure rate (clinical cure<br />
plus microbiologic cure) was assessed on post-<br />
treatment Day 14.<br />
Results demonstrated that 23% of the patients in<br />
the active treatment group achieved the primary end<br />
point, compared with 10% of those in the vehicle<br />
group (P=.005) (Figure 10). A total of 38% and 11%<br />
of patients in the active and vehicle treatment groups,<br />
respectively, achieved the secondary end point of<br />
clinical cure (P
<strong>Diaper</strong> <strong>Dermatitis</strong> | <strong>Appropriate</strong> <strong>Evaluation</strong> & Optimal Management Strategies<br />
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1. Atherton DJ. A review of the pathophysiology, prevention and treatment of irritant<br />
diaper dermatitis. Curr Med Res Opin. 2004;20(5):645–649.<br />
2. Ward DB, Fleischer AB Jr, Feldman SR, Krowchuk DP. Characterization of diaper<br />
dermatitis in the United States. Arch Pediatr Adolesc Med. 2000;154(9):943–946.<br />
3. Adalat S, Wall D, Goodyear H. <strong>Diaper</strong> dermatitis - frequency and contributing factors<br />
in hospital attending children. Pediatr Dermatol. 2007;24(5):483–488.<br />
4. Jordan WE, Lawson KD, Berg RW, Franxman JJ, Marrer AM. <strong>Diaper</strong> dermatitis:<br />
frequency and severity among a general infant population. Pediatr Dermatol.<br />
1986;3(3):198–207.<br />
5. Dixon PN, Warin RP, English MP. Role of Candida albicans infections in napkin rashes.<br />
BMJ. 1969;2(5648):23–27.<br />
6. Montes LF, Pittillo RF, Hunt D, Narkates AJ, Dillon HC. Microbial flora of infant’s skin:<br />
comparison of types of microorganisms between normal skin and diaper dermatitis.<br />
Arch Dermatol. 1971;103(4):400–406.<br />
7. Leyden JJ, Kligman AM. The role of microorganisms in diaper dermatitis. Arch<br />
Dermatol. 1978;114(1):56–59.<br />
8. Ferrazzini G, Kaiser RR, Hirsig Cheng SK, et al. Microbiological aspects of diaper dermatitis.<br />
Dermatology. 2003;206(2):136–141.<br />
9. Hydrocortisone topical [package insert] http://www.safemedication.com/<br />
searchresults/DisplayDrug.aspx?id=a682793. Accessed March 16, 2009.<br />
10. Benjamin L. Clinical correlates with diaper dermatitis. Pediatrician. 1987;14<br />
(suppl 1):21–26.<br />
11. Krol A, Krafchik B. Chapter 16, <strong>Diaper</strong> Area Eruptions. In: Eichenfield LF, Frieden IJ,<br />
Esterly NB, eds. Neonatal Dermatology. 2nd ed. Philadelphia, PA: Elsevier Saunders;<br />
2008:245–266.<br />
12. Vusion ® Ointment [package insert]. Princeton, NJ: Barrier Therapeutics; 2006.<br />
13. Berg RW. Etiologic factors in diaper dermatitis: a model for development of improved<br />
diapers. Pediatrician. 1987;14(suppl 1):27–33.<br />
14. Leyden JJ. <strong>Diaper</strong> <strong>Dermatitis</strong>. Dermatol Clin. 1986;4(1):23–28.<br />
15. Leyden JJ, Katz S, Stewart R, Kligman AM. Urinary ammonia and ammonia-producing<br />
microorganisms in infants with and without diaper dermatitis. Arch Dermatol.<br />
1977;113(12):1678–1680.<br />
16. Berg RW, Buckingham KW, Stewart RL. Etiologic factors in diaper dermatitis: the role<br />
of urine. Pediatr Dermatol. 1986;3(2):102–106.<br />
17. Austin AP, Milligan MC, Pennington K, Tweito DH. A survey of factors associated with<br />
diaper dermatitis in thirty-six pediatric practices. J Pediatr Health Care.<br />
1988;2(6):295–299.<br />
18. Berg RW, Milligan MC, Sarbaugh FC. Association of skin wetness and pH with diaper<br />
dermatitis. Pediatr Dermatol. 1994;11(1):18–20.<br />
19. Andersen PH, Bucher AP, Saeed I, Lee PC, Davis JA, Maibach HI. Faecal enzymes:<br />
in vivo human skin irritation. Contact <strong>Dermatitis</strong>. 1994;30(3):152-158.)<br />
20. Leyden JJ. Corn starch, Candida albicans, and diaper rash. Pediatr Dermatol.<br />
1984;1(4):322–325.<br />
21. Rebora A, Marples RR, Kligman AM. Erosio interdigitalis blastomycetica. Arch Dermatol.<br />
1973;108(1):66–68.<br />
22. Maibach HI, Kligman AM. The biology of experimental human cutaneous moniliasis<br />
(Candida albicans). Arch Dermatol. 1962;85(2):233–257.<br />
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23. Rebora A, Leyden JJ. Napkin (diaper) dermatitis and gastrointestinal carriage of<br />
Candida albicans. Br J Dermatol. 1981;105(5):551–555.<br />
24. Honig PJ, Gribetz B, Leyden JJ, McGinley KJ, Burke LA. Amoxicillin and diaper dermatitis.<br />
J Am Acad Dermatol. 1988;19:275–279.<br />
25. Hoppe JE, Hahn H, for the Antimycotics Study Group. Randomized comparison of two<br />
nystatin oral gels with miconazole oral gel for treatment of oral thrush in infants.<br />
Infection. 1996;24(2):136–139.<br />
26. Akin F, Spraker M, Aly R, Leyden J, Raynor W, Landin W. Effects of breathable<br />
disposable diapers: reduced prevalence of Candida and common diaper dermatitis.<br />
Pediatr Dermatol. 2001;18(4):282–290.<br />
27. Humphrey S, Bergman JN, Au S. Practical management strategies for diaper dermatitis.<br />
Skin Therapy Lett. 2006;11(7):1–6.<br />
28. Ekingen G, Isken T, Agir H, Öncel S, Günlemez A. Fournier’s gangrene in childhood:<br />
a report of 3 infant patients. J Pediatr Surg. 2008;43(12):e39–42.<br />
29. Rattet JP, Headley JL, Barr RJ. <strong>Diaper</strong> dermatitis with psoriasiform ID eruption. Int J<br />
Dermatol. 1981;20(2):122–125.<br />
30. Farber EM, Mullen RH, Jacobs AH, Nall L. Infantile psoriasis: a follow-up study. Pediatr<br />
Dermatol. 1986;3(3):237–243.<br />
31. Odio M, Friedlander SF. <strong>Diaper</strong> dermatitis and advances in diaper technology.<br />
Curr Opin Pediatr. 2000;12(4):342–346.<br />
32. Baer EL, Davies MW, Easterbrook KJ. Disposable nappies for preventing napkin dermatitis<br />
in infants. Cochrane Database Syst Rev. 2006;3:CD004262.<br />
33. Baldwin S, Odio MR, Haines SL, O’Connor RJ, Englehart JA, Lane AT. Skin benefits<br />
from continuous topical administration of a zinc oxide/petrolatum formulation by a<br />
novel disposable diaper. J Eur Acad Dermatol Venereol. 2001;15(suppl 1):5–11.<br />
34. Adam R. Skin care of the diaper area. Pediatr Dermatol. 2008;25(4):427–433.<br />
35. Shin HT. <strong>Diaper</strong> dermatitis that does not quit. Dermatol Ther. 2005;18(2):124–135.<br />
36. Brouillette F, Weber ML. Massive aspiration of talcum powder by an infant. Can Med<br />
Assoc J. 1978;119(4):354–355.<br />
37. Pfenninger J, D’Apuzzo V. Powder aspiration in children. Report of two cases. Arch Dis<br />
Child. 1977;52(2):157–159.<br />
38. Railan D, Wilson JK, Feldman SR, Fleischer AB. Pediatricians who prescribe clotrimazolebetamethasone<br />
dipropionate (Lotrisone) often utilize it in inappropriate settings<br />
regardless of their knowledge of the drug’s potency. Dermatol Online J. 2002;8(2):3.<br />
39. West DP, Worobec S, Solomon LM. Pharmacology and toxicology of infant skin.<br />
J Invest Dermatol. 1981;76(3):147–150.<br />
40. Spraker MK, Gisoldi EM, Siegfried EC, et al. Topical miconazole nitrate ointment in<br />
the treatment of diaper dermatitis complicated by candidiasis. Cutis. 2006;77(2):<br />
113–120.<br />
41. do Rego MA, Koga-Ito CY, Jorge AO. Effects of oral environment stabilization<br />
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17(4):332 –336.<br />
42. Spectazole ® [package insert]. Skillman, NJ: Ortho Pharmaceutical Corporation; 2001.
VUSION ®<br />
(0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum)<br />
Ointment<br />
Rx only.<br />
FOR TOPICAL USE ONLY.<br />
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.<br />
DESCRIPTION<br />
VUSION Ointment contains the synthetic antifungal agent, miconazole nitrate<br />
(0.25%), zinc oxide (15%) and white petrolatum (81.35%) for topical use.<br />
The chemical name of miconazole nitrate is 1-[2,4-dichloro-�-{(2,4dichlorobenzyl)oxy}<br />
phenethyl] imidazole mononitrate with empirical formula<br />
C18H14Cl4N2�����3 and molecular weight of 479.15. The structural formula of<br />
miconazole nitrate is as follows:<br />
Cl<br />
Cl<br />
Cl<br />
Cl<br />
O<br />
The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.<br />
The white petrolatum, which is obtained from petroleum and is wholly or nearly<br />
decolorized, is a purified mixture of semisolid saturated hydrocarbons having the<br />
general chemical formula C nH 2n+2. The hydrocarbons consist mainly of branched and<br />
unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as<br />
stabilizer.<br />
Each gram of VUSION Ointment contains 2.5 mg of miconazole nitrate USP, 150 mg<br />
of zinc oxide USP, 813.5 mg of white petrolatum USP containing butylated hydroxytoluene,<br />
trihydroxystearin and Chemoderm ® 1001/B fragrance. 1<br />
VUSION Ointment is a smooth, uniform, white ointment.<br />
1 Chemoderm ® is a registered trademark of Firmenich Inc.<br />
CLINICAL PHARMACOLOGY<br />
Pharmacokinetics:<br />
The topical absorption of miconazole from an ointment containing 0.25% miconazole<br />
nitrate, 15% zinc oxide and 81.35% white petrolatum was studied in male and female<br />
infants (n=18) with diaper dermatitis ranging in age from 1 month to 12 months. After<br />
application at every diaper change for 7 days, the plasma concentrations of miconazole<br />
were nondetectable (1% for subjects who were treated with VUSION were approximately the<br />
same in type and frequency as for subjects who were treated with zinc oxide/white<br />
petrolatum ointment.<br />
The potential for dermal toxicity of VUSION Ointment formulation was investigated in<br />
healthy adult volunteers in four topical safety studies. These studies were conducted<br />
to assess the potential for contact phototoxicity, photoallergy, sensitization, and<br />
cumulative irritation potential. Phototesting was conducted with UV-A only. Results<br />
indicated that VUSION Ointment did not induce a contact dermal phototoxic response,<br />
contact dermal photoallergic response, or contact dermal sensitization in adult<br />
subjects. In addition, VUSION Ointment did not show any evidence of cumulative<br />
irritation potential in adult subjects.<br />
OVERDOSAGE<br />
VUSION Ointment is intended for topical use only. Young children are at risk for accidentally<br />
ingesting VUSION Ointment. A health care provider or poison control center<br />
should be contacted in the event of accidental ingestion.<br />
DOSAGE AND ADMINISTRATION<br />
Before applying VUSION Ointment, gently cleanse the skin with lukewarm water and<br />
pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the<br />
diaper area.<br />
VUSION Ointment should be applied to the affected area at each diaper change for<br />
7 days. Treatment should be continued for the full 7 days, even if there is improvement.<br />
The safety of VUSION Ointment when used for longer than 7 days is not known.<br />
Gently apply a thin layer of VUSION Ointment to the diaper area with the fingertips.<br />
VUSION Ointment should not be rubbed into the skin as this may cause additional<br />
irritation. Thoroughly wash hands after applying VUSION Ointment.<br />
VUSION Ointment should be used for the adjunctive treatment of diaper dermatitis<br />
only when complicated by candidiasis, as documented by microscopic evidence<br />
of pseudohyphae and/or budding yeasts, in immunocompetent pediatric patients<br />
4 weeks and older. VUSION Ointment should be used as part of a treatment regimen<br />
that includes measures directed at the underlying diaper dermatitis, including gentle<br />
cleansing of the diaper area and frequent diaper changes.<br />
VUSION Ointment should not be used as a substitute for frequent diaper changes.<br />
VUSION Ointment should not be used to prevent the occurrence of diaper dermatitis,<br />
since preventative use may result in the development of drug resistance.<br />
HOW SUPPLIED<br />
VUSION Ointment is a smooth, uniform, white ointment supplied in an aluminum<br />
tube, as follows:<br />
5g sample (NDC 13478-002-03)<br />
50g (NDC 13478-002-04)<br />
Storage Conditions<br />
Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with<br />
excursions permitted between 15°C and 30°C (59°F and 86°F).<br />
Keep out of reach of children.<br />
For additional information, please call toll free 1-866-440-5508.<br />
Manufactured By:<br />
DSM Pharmaceuticals, Inc.<br />
Greenville, NC 27834<br />
For:<br />
Barrier Therapeutics, Inc.<br />
600 College Road East<br />
Princeton, NJ 08540<br />
www.barriertherapeutics.com<br />
VU-501 April 2007<br />
U.S. Patent No. 4,911,932<br />
VUSION ®<br />
(0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum) Ointment<br />
Patient Package Insert<br />
For Skin Use Only<br />
Read the Patient Information that comes with VUSION Ointment before you use it on<br />
your child. This leaflet does not take the place of talking to your health care provider<br />
about your child’s medical condition or treatment. If you have any questions or if you<br />
are not sure about any of the information on VUSION Ointment, ask your health care<br />
provider, or pharmacist.<br />
What is VUSION Ointment?<br />
VUSION Ointment is a prescription skin medicine used to treat diaper rash that also<br />
has a yeast infection in children who have a normal immune system. VUSION<br />
Ointment contains medicines that will help treat the yeast infection and the diaper<br />
rash, but you must also change your child’s diapers very often so that your child<br />
is not wearing a wet or soiled diaper. Even if you use VUSION Ointment, diaper<br />
rash will not go away if you do not keep your child’s diaper area clean and dry. You<br />
should use water or a very mild cleanser to clean your child’s diaper area. VUSION<br />
Ointment is not used to prevent diaper rash or to be used for more than 7 days.<br />
Who should not use VUSION Ointment?<br />
VUSION Ointment is not for treatment of all cases of diaper rash. VUSION Ointment<br />
is only for diaper rash that also has a yeast infection. Most cases of diaper rash<br />
do not need the yeast medicine that is in VUSION Ointment because most cases of<br />
diaper rash do not also have a yeast infection.<br />
Your health care provider will need to do a special test to tell if your child’s diaper<br />
rash also has a yeast infection. Do not use VUSION Ointment on your child’s diaper<br />
rash unless your health care provider tells you that there is also a yeast infection.<br />
Do not use VUSION Ointment on any other children.<br />
Do not use VUSION Ointment on your child’s diaper rash if they are allergic to anything<br />
in it. See the end of this leaflet for a list of ingredients in VUSION Ointment.<br />
How should I use VUSION Ointment on my child?<br />
VUSION Ointment is applied to the skin on your child’s diaper area at each diaper<br />
change for 7 days.<br />
Apply VUSION Ointment for the full 7 days even if the diaper rash starts to go away.<br />
Call your child’s health care provider if the diaper rash gets worse or does not go away<br />
with 7 days of treatment with VUSION Ointment. VUSION Ointment should not be<br />
used for more than 7 days.<br />
To apply VUSION Ointment:<br />
�����������������������������������������������������������������������������������<br />
may also use a very mild soap. Pat the area dry with a soft towel.<br />
������ ����� ����������� ���� ������� ������ �� ����� ������ ��� ������� ��������� ��� ����<br />
child’s diaper area at each diaper change. Do not rub VUSION Ointment into your<br />
child’s skin. Rubbing the skin can cause more irritation.<br />
���������������������������������������������������������������<br />
VUSION Ointment is for skin use only.<br />
Call your child’s health care provider or poison control center right away if any<br />
VUSION Ointment is swallowed. Call your child’s health care provider if VUSION<br />
Ointment gets in the eye.<br />
What other steps will help diaper rash go away?<br />
�����������������������������������������������������������������������������������<br />
��������������������������������������������������������������������������������������<br />
from the front to back using warm (not hot) water. You may also use a mild soap.<br />
Rinse the diaper area well. Pat dry with a soft towel.<br />
�������������������������������������������������<br />
�����������������������������������diaper rash will not go away if you do not keep<br />
your child’s diaper area clean and dry.<br />
What are the possible side effects of VUSION Ointment?<br />
Ointment may cause irritation, but this is not common. You should call your child’s<br />
health care provider if irritation appears or if the diaper rash gets worse.<br />
How should I store VUSION Ointment?<br />
�������� ������� ��������� ��� ����� ������������ �������� ����� ��� ����� ������ ��<br />
30°C).<br />
��Keep VUSION Ointment out of the reach of children.<br />
General information about VUSION Ointment<br />
Medicines are sometimes prescribed for conditions that are not mentioned in patient<br />
information leaflets.<br />
Do not use VUSION Ointment for a condition for which it was not prescribed. Do not<br />
give VUSION Ointment to other children, even if they have the same symptoms your<br />
child has. It may harm them.<br />
This leaflet summarizes the most important information about VUSION Ointment. If<br />
you would like more information, talk to your child’s health care provider. You can ask<br />
your child’s health care provider or pharmacist for information about VUSION<br />
Ointment that is written for health care professionals.<br />
You can also call Barrier Therapeutics, Inc., Customer Information Center toll free<br />
at 1-866-440-5508.<br />
What are the ingredients in VUSION Ointment?<br />
Active Ingredients: miconazole nitrate, zinc oxide and white petrolatum<br />
Inactive Ingredients: trihydroxystearin, butylated hydroxytoluene (BHT) and<br />
Chemoderm ® 1001/B fragrance<br />
Marketed by: Manufactured By:<br />
Barrier Therapeutics, Inc. DSM Pharmaceuticals, Inc.<br />
Princeton, NJ 08540-6697 USA Greenville, NC 27834<br />
www.barriertherapeutics.com<br />
April 2007 VU-501 U.S. Patent No. 4,911,932<br />
April 2009 1
©2009 Medisys Health Communications inc. April 2009.<br />
All rights reserved. printed in USA.<br />
E0012Z<br />
Vusion is a registered trademark of STiEFEl