09.11.2012 Views

Diaper Dermatitis: Appropriate Evaluation ... - ModernMedicine

Diaper Dermatitis: Appropriate Evaluation ... - ModernMedicine

Diaper Dermatitis: Appropriate Evaluation ... - ModernMedicine

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

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 />

April 2009


<strong>Diaper</strong> <strong>Dermatitis</strong> | <strong>Appropriate</strong> <strong>Evaluation</strong> & Optimal Management Strategies<br />

April 2009<br />

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 />

April 2009


<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 />

April 2009


<strong>Diaper</strong> <strong>Dermatitis</strong> | <strong>Appropriate</strong> <strong>Evaluation</strong> & Optimal Management Strategies<br />

April 2009<br />

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 />

April 2009


<strong>Diaper</strong> <strong>Dermatitis</strong> | <strong>Appropriate</strong> <strong>Evaluation</strong> & Optimal Management Strategies<br />

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 />

April 2009 11


<strong>Diaper</strong> <strong>Dermatitis</strong> | <strong>Appropriate</strong> <strong>Evaluation</strong> & Optimal Management Strategies<br />

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 />

rEFErEncES<br />

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 />

1 April 2009<br />

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 />

procedures on counts of Candida spp. in children. Pesqui Odontol Bras. 2003;<br />

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

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!