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Pediatric Dermatology - 2014 - Blume Peytavi - Prevention of Diaper Dermatitis in Infants A Literature Review

This literature review examines the prevention of diaper dermatitis (DD) in infants, highlighting its prevalence and the importance of effective skin care practices. The review identifies 13 studies that evaluate various nonmedical skin care methods, such as cleansing, bathing, and topical applications, but finds insufficient evidence to conclusively recommend specific practices for DD prevention. The authors call for high-quality randomized clinical trials to better understand the effectiveness of these skin care practices.

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0% found this document useful (0 votes)
32 views17 pages

Pediatric Dermatology - 2014 - Blume Peytavi - Prevention of Diaper Dermatitis in Infants A Literature Review

This literature review examines the prevention of diaper dermatitis (DD) in infants, highlighting its prevalence and the importance of effective skin care practices. The review identifies 13 studies that evaluate various nonmedical skin care methods, such as cleansing, bathing, and topical applications, but finds insufficient evidence to conclusively recommend specific practices for DD prevention. The authors call for high-quality randomized clinical trials to better understand the effectiveness of these skin care practices.

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kimthuyvy92
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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REVIEWS

Pediatric Dermatology Vol. 31 No. 4 413–429, 2014

Prevention of Diaper Dermatitis in Infants—a


Literature Review
Ulrike Blume-Peytavi, M.D.,* Matthias Hauser, Ph.D.,† Lena L€ unnemann, M.D.,*
Georgios N. Stamatas, Ph.D.,‡ Jan Kottner, Ph.D.,* and Natalie Garcia Bartels, M.D.*
e—
*Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charit
atsmedizin Berlin, Berlin, Germany, †Johnson & Johnson GmbH, Neuss, Germany, ‡Johnson & Johnson
Universit€
Sante Beaut
e France, Issy-les-Moulineaux, France

Abstract: Diaper dermatitis (DD) is one of the most common skin


conditions in neonates and infants, with a peak between the ages of 9 and
12 months. Appropriate skin care practices that support skin barrier
function and protect the buttocks skin from urine and feces are supposed
to be effective in the prevention of DD. Despite many recommendations for
parents and caregivers on proper diaper skin care, there is no up-to-date
synthesis of the available evidence to develop recommendations for DD
prevention practice. Therefore we performed a systematic literature
review on the efficacy of nonmedical skin care practices on the diapered
area of healthy, full-term infants ages 0 to 24 months. We identified 13
studies covering skin care practices such as cleansing, bathing, and
application of topical products. DD prevalence and incidence and
physiologic skin parameters were used as efficacy parameters. The
results of this review indicate that cleansing of the diaper area using baby
wipes or water and a washcloth have comparable effects on diapered skin.
Bathing with a liquid baby cleanser twice weekly seems comparable with
water alone. The application of ointments containing zinc oxide or
petrolatum with or without vitamin A seems to have comparable effects
on DD severity. There seems to be no information on whether single skin
care practices such as cleansing, bathing, and application of topical
preparations can prevent DD. High-quality randomized clinical trials are
needed to show the effectiveness of skin care practices for controlling
and preventing DD.

Diaper dermatitis (DD), also known as napkin the skin in the diaper area (1,2). DD is one of the most
dermatitis, nappy rash, or diaper rash, is a nonspecific common skin conditions in neonates and infants. Its
term used to describe any inflammatory reaction of prevalence is estimated to be between 25% and 50%,

Address correspondence to Ulrike Blume-Peytavi, M.D.,


Department of Dermatology and Allergy, Clinical Research Center
for Hair and Skin Science, Charite—Universit€atsmedizin Berlin,
Chariteplatz 1, 10117 Berlin, Germany, or e-mail: crc-office@
charite.de.

DOI: 10.1111/pde.12348

© 2014 Wiley Periodicals, Inc. 413


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414 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

depending on age and the methods applied in specific (13,21,22), whereas others recommend disposable
studies (3–5). In addition, physicians and parents do baby wipes for cleansing if a clean cloth and water
not report many cases of DD because they resolve are considered insufficient or are not available
after a few days without the need for medical (15,20) or for use in general, as wipes are thought
treatment (6). Incidence peaks between the ages of 9 to be as good as or better than water-soaked
and 12 months (3,7). In a large study in the United washcloths (16,23–25).
Kingdom, the prevalence of DD (as reported by Diaper dermatitis causes much discomfort and
mothers) during the first 4 weeks of life was approx- stress in infants (2,7,18,26). For effective prevention,
imately 25%. Of those affected, a minority of 6% had parents and caregivers need evidenced-based infor-
“very” or “quite” bad rashes (4). mation for guidance and assistance. The aim of this
A combination of factors, of which the most literature review is to evaluate the available evidence
important is prolonged contact of the skin with urine on the efficacy of skin care practices for the
and feces, causes DD (1,8). Occlusion increases skin prevention of DD in healthy infants ages 0 to
hydration and raises skin pH, while exposure to fecal 24 months.
enzymes damages the integrity of the skin barrier and
increases its permeability. Poor barrier function
makes the skin susceptible to irritant and microbial METHODS
invasion, leading to localized skin inflammation (1,9).
Search Strategy
Early signs of DD appear as asymptomatic mild
erythema over a limited surface area of the skin, with A literature search was performed in the PubMed
minimal maceration and chafing (10). The areas of the and Embase databases to identify relevant articles
skin that are most affected by DD are the buttocks, published between 1970 and July 2012. The follo-
genitals, abdomen, perianal area, and thighs. As the wing search strings were applied (* indicates trun-
condition progresses, moderate erythema with mac- cation):
eration affecting a larger surface area and skin  skin care or skin barrier* or skin treatment* or
breakdown leading to exudative or ulcerated lesions skin cleaning or skin cleansing
can ensue (10).  cream* or ointment* or emollient* or lotion* or
To treat DD, experts recommend frequent diaper oil* or vaseline* or hamamelis or aloe vera or
changes; minimization of diaper wear; use of dispos- zinc*
able, superabsorbent, and breathable diapers instead  nappy or nappies or napkin* or diaper* or
of cloth diapers; use of topical preparations; and wipe*
parent education (8,11–16). More severe forms of DD  Each of these search strings was combined with
with clinical signs of secondary infections require one of the following key words: baby or babies or
medical attention, with careful diagnosis and proper infant* or children or neonate* or newborn* or
treatment (12,15). toddler* [title/abstract]; study or studies or trial*
The best management of DD is prevention. In or RCT or randomized or investiga* or obser-
general, approaches that cure DD are also assumed vat* or review* [title/abstract].
to be effective prevention measures (17). Neverthe-
less, many experts point to the lack of controlled Our search was restricted to articles in English and
trial data to support any particular prevention German.
practice (8,18). Rowe et al (18) could not find any
published clinical studies comparing the effectiveness Inclusion Criteria
of different over-the-counter barrier preparations for
the prevention of DD. Despite the large number of  Healthy, full-term infants, 0 to 24 months old.
clinical studies on disposable diapers, there is only  No signs of DD at inclusion
limited evidence from randomized clinical trials that  Skin care practices applied to prevent DD or to
disposable diapers are more effective in the preven- maintain skin barrier integrity, including proce-
tion of DD than cloth diapers (19) or, more dures such as bathing or cleansing and products
generally, that any diaper type has distinct advanta- such as ointments, creams, and oils.
ges over others. In addition, recommendations on  Study design: randomized, quasi-randomized,
the proper way to cleanse the diaper area are or nonrandomized trials, cohort studies, case
conflicting. Some professionals consider warm water series, case–control studies, or cross-sectional
and cotton balls to be the criterion standard studies.
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Blume-Peytavi et al: Prevention of Diaper Dermatitis 415

Exclusion Criteria to individual studies (27). For intervention studies,


LoE I (systematic review), II (randomized controlled
 Preterm babies or intensive care unit (ICU) or observational study with dramatic effect), III
patients. (nonrandomized controlled cohort or follow-up
 Babies with any chronic dermatologic disease, study), IV (case series or case–control studies), and
Hirschsprung’s disease, anorectal malforma- V (mechanism-based reasoning) were used. In cases
tions, or ostomy takedowns. of obvious methodologic flaws the LoE was down-
 Pharmaceutical treatment of DD, such as corti- graded.
costeroids, antifungals, antibiotics, and antisep-
tics.
 Diaper technology. RESULTS
Our search strategy revealed a total of 227 articles.
After exclusion of all reviews, reports, and articles
Selection of Studies that did not meet the inclusion criteria, 13 remaining
Two reviewers independently assessed the titles and studies were subjected to critical appraisal.
abstracts of identified articles for relevance according to The 13 studies selected for review were all pub-
the inclusion and exclusion criteria. Publications iden- lished in English: 6 randomized controlled trials
tified as potentially relevant were retrieved and fully (RCTs) with LoE II, 3 controlled studies without
reviewed. Disagreements were resolved by discussion randomization with LoE III, and 4 studies with LoE
between the reviewers. Additional relevant publications IV. All studies had evaluated different skin practices
were identified in the reference lists of publications that aimed to keep the infant’s skin in the diaper area
selected from the searches described above. An Internet healthy or to prevent DD. We categorized the studies
search using Google as the search engine was conducted according to three main topics:
to obtain additional relevant information. Effects of cleansing procedures (water, washcloths,
and baby wipes)
Outcome Variables Effects of bathing procedures
Effects of topical skin products
As outcome measures, clinical parameters such as the
prevalence and incidence of DD, erythema, dryness, The study details and results are summarized in
redness, skin surface roughness or friction, and chronological order in Tables 1, 2, and 3.
physiologic skin parameters such as transepidermal
water loss (TEWL), stratum corneum hydration Effect of Cleansing Procedures
(SCH), skin surface pH, and moisture accumulation
rate (MAT) were chosen. We identified eight studies that analyzed the effects of
cleansing procedures on clinical or functional skin
parameters of the diaper area (Table 1). All but one
Data Items study compared the use of commercially available
Information on the characteristics of participants baby wipes with that of water and washcloth; the
(including age, health status, absence of DD, and other trial examined the effects of different wipes (29).
diagnostic methods), type of intervention, duration of All baby wipes used were water based, but differed
intervention, outcome measures (DD, erythema, widely in ingredients such as emollients, preservatives,
TEWL, SCH, MAT, skin surface pH, dryness, skin fragrances, and pH of the lotion. The duration of
surface roughness or friction), and adverse effects treatment varied from 1 day to 8 weeks. Six trials
were extracted from each included trial. analyzed healthy infants ages 1 to 24 months and two
For some outcome variables, data were extracted trials studied neonates (25,29). The severity of DD
from the graphs presented in the publications. No was the primary outcome measure in three studies and
study authors were contacted. a secondary outcome measure in two studies. SCH,
skin surface pH, TEWL, microbiologic colonization,
and interleukin-1a were used as primary or secondary
Risk of Bias in Individual Studies outcome variables.
No formal risk of bias assessment was conducted, In two of the four studies that compared the use of
but levels of evidence (LoE) according to the Oxford baby wipes with that of water and washcloths for 1 to
Centre for Evidence-Based Medicine were assigned 4 weeks, slightly but significantly higher levels in the
TABLE 1. Evidence of the Effects of Skin Care on the Diapered Area in Infants: Washing and Cleansing
Study endpoints
Sample and assessment
Study Treatment Level of and group timepoints and
Author Topic design duration Intervention evidence sizes Age sites Results Remarks

Priestley Comparison of Prospective, 8 weeks After 2-week III 302 infants: 4–12 months (1) DD severity (1) DD severity: No randomization
et al (28) cleansing with double- run-in phase ≥60 infants on 5-point scale no significant details; no data
four water-based blind, (water and per group (0 = no findings differences shown for DD
wipes with parallel- baby bath (no further to 4 = requires between study severity; zinc
different ingredients group, soap only), details) medication) groups (no and castor oil
(emollients, four-arm infants were (2) Skin surface data shown) cream could be
preservatives) and study cleansed pH (skin pH (2) Mean pH used during the
pH (2.8–5.4) in with one meter 900, in diaper area study period;
the lotion type of test Courage & at visit malfunction of
wipe for Khazaka, 6: 5.0  0.1 pH meter
8 weeks Germany) to 5.7  0.1 described
Assessments depending
on three skin on pH of the
areas (thigh wipes; differences
outside significant
diaper = control, between
center of left brand with
buttock and lowest
symphysis pH (2.8)
pubis) at (p < 0.01)
baseline and and other
every 2 weeks wipes and
416 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

for 10 weeks for this brand


(six visits) between
visits 2
and 6
(p < 0.004)
Ehretsmann Comparison of Investigator- 2 weeks After 1-week III 102 infants, 6–24 months (1) DD severity (1) Mean DD No randomization
et al (23) cleansing with blind, run-in phase group size on 7-point scale severity process described;
wet wipe parallel- with standard not reported (0.0 = none scores in the possible
(water-based, group, diaper, infants to 3.0 = severe) intertriginous Hawthorne
alcohol-free two-arm were cleansed Assessments area: 0.8 in effect assumed
lotion—pH study with the test at four sites wet wipe
5.5—on nonwoven wet wipe (genitals, group vs
clothlike or usual intertriginous, 1.0 in water
substrate) and cleansing perianal, group (p < 0.05).
cotton wool material buttocks) at Similar results
balls plus water plus water baseline and observed for
for 2 weeks two times erythema
per week (data not
over 2 weeks shown).
(four visits) DD severity
scores in
genital,
perianal, and
buttock areas
not statistically
different between
groups (absolute
values not
reported)

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TABLE 1. Continued
Study endpoints
Sample and assessment
Study Treatment Level of and group timepoints and
Author Topic design duration Intervention evidence sizes Age sites Results Remarks

Odio et al Comparison of Prospective, 1 week After 1-week II 90 infants: 15  1.0 months (1) DD severity Results wipe
(24) cleansing with randomized, run-in phase 45 infants (erythema) group vs
baby wipes double-blind, (usual cleansing per group on 7-point scale water group:
(Pampers Baby parallel-group practice), (0.0 = none (1a) DD severity
Fresh wipes) and comparison infants were to 3.0 = severe) genital region:
cotton washcloth cleansed (2) TEWL 1.1 vs 0.8
plus water with test wipe (ServoMed EP-1 (p > 0.05)
or washcloth evaporimeter) (1b) DD severity
plus water (3) Skin surface perianal region:
for 8 days roughness 1.2 vs 1.4
Rq (area sampling (p < 0.05)
with SILFLO (approximate
catalyst material values
and analysis of estimated
replicas with from figures)
three-dimensional (2a) TEWL
system based on pubis 15 minutes
technique of after diaper
moire removal:
interferometry) 9.9  0.5 vs
Assessments at 10.5  1.0
baseline and days (2b) TEWL
1, 6, and 7 buttocks
15 minutes
after diaper
removal:
7.2  0.8 vs
8.0  0.8
(3) Rq
10 minutes
post wiping:
11.5  0.4
vs 12.5  0.5
(n = 24),
(p < 0.05)
Senses et al Comparison of Quasi- IV 173 infants: 1–24 months Bacterial Results wipe Weak study design;
(31) cleansing with experimental, wipes group colonization group vs no study details
baby wet wipes two-arm study (n = 96); Culturing of water group: on intervention
(Uni Wipes, napkins plus periurethral Presence of and duration of
Istanbul) vs water group samples under uropathogens treatment
water plus (n = 77) aerobic conditions with skin flora:
napkins on and testing for 61.5% vs
periurethral flora uropathogenic 66.2% (p > 0.05).
bacteria and Presence of
skin flora uropathogens
only: 18.7%
vs 14.3%
(p > 0.05)
Adam et al Comparison of Prospective, 2 weeks After 1-week IV 15 infants No data Skin surface pH Mean pH Unclear reporting:
Blume-Peytavi et al: Prevention of Diaper Dermatitis

(30) cleansing with randomized, washout measurement change on no details on


baby wipes vs double-blind, period (use (pH meter, buttock vs randomization,
417

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TABLE 1. Continued
Study endpoints
Sample and assessment
Study Treatment Level of and group timepoints and
Author Topic design duration Intervention evidence sizes Age sites Results Remarks

washcloth plus parallel group, of standard Courage & nondiapered blinding


water two-arm in- wipe), Khazaka, control site: procedure, group
use trial infants were Germany) 0.4 in test size, age range;
cleansed with on buttocks at wipe group no absolute
test wipe baseline and vs 1.15 in values reported
or washcloth weeks 1 and 2 washcloth
plus water plus water
for 2 weeks group
(p = 0.003)
Adam et al Comparison of Cohort study 1-day Infants visited IV 50 infants: No data Skin surface pH pH values at Unclear reporting:
(30) cleansing with with 10 babies assessment the clinic 10 infants measurement last timepoint: group size, age
test baby wipes, per group after defecation per group on buttocks 6.7 in alkaline range; no
standard wipes, and were (pH meter, soap group, p-values reported
washcloth and cleansed by Courage & 6.5 in synthetic
alkaline soap, caregivers Khazaka, detergent
washcloth plus with test wipes Germany) group, 6.2 in
water, and washcloth or washcloth every washcloth plus
and synthetic and usual 30 seconds water and
detergent cleansing for 6 minutes “other wipe”
agent groups, 5.9 in
test wipe group;
pH values test
418 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

wipe vs all
other cleansing
procedures
statistically
significant
Lavender Comparison of Prospective, 4 weeks Infants were II 280 infants: Newborn DD severity Results of wipe Possible
et al (25) cleansing with randomized, cleansed 140 infants (48 hours grading scale group vs Hawthorne
alcohol-free baby assessor- with test per group after birth) Erythema water group effect in DD
wipes (Baby blinded, wipes or (Mexameter (1a) Mother- assessment,
Skincare controlled, cotton MX 18, CK reported DD: mothers
Fragrance Free equivalence wool plus Electronic 1.0 vs 2.5 unblinded
Wipes, Johnson trial water for Cologne, (p = 0.02)
& Johnson, 4 weeks Germany) (1b) Midwife-
pH ~4.9) vs SCH on the reported DD
cotton wool buttocks prevalence at
plus water (Corneometer week 4: 12.9%
Derma Unit vs 16.1%
SSC 3, CK (p = 0.3)
Electronic) (2) Log
TEWL (Aquaflux erythema:
AF200, Biox 6.3  0.1 vs
Systems, 6.3  0.1
Southwark (p = 0.18)
Campus, (3) SCH
London) (PP analysis):
Skin surface 64.6  12.4 vs
pH (pH meter) 63.6  14.3
Microbial (p = 0.53)
examination (4) Mean

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TABLE 1. Continued
Study endpoints
Sample and assessment
Study Treatment Level of and group timepoints and
Author Topic design duration Intervention evidence sizes Age sites Results Remarks

(coliform TEWL:
bacteria 17.8  7.0
and Candida vs 19.0  10.6
spp.) (p = 0.49)
Assessments at (5) Skin pH:
baseline 5.9  0.6 vs
and week 4 5.7  0.6
(p = 0.36)
(6a) Coliform
bacteria: 2.0
vs 4.9 (p = 0.91)
(6b) Candida: 0
in both groups
(p = 0.45)
Garcia Comparison of Prospective, 4 weeks Infants were II 44 infants: Newborn (1) TEWL, SCH, (1a) Mean TEWL
Bartels cleansing with randomized, cleansed wipes group (≤48 hours) and skin surface on buttock on
et al (29) wet wipes controlled with test (n = 21); pH (Courage & day 28: 9.6 in
(Penaten trial wipes or water Khazaka, wipe group vs
baby wet wipes washcloth group Germany); 11.2 in water
with aloe vera, plus water (n = 23) (2) Epidermal group (p = 0.007)
Johnson & for 4 weeks desquamation (1b, 1c, 2, 3 and 4):
Johnson) vs cotton (D-Squame) SCH, skin pH,
washcloth plus (3) Neonatal Skin IL-1, desquamation
water Condition Score and Neonatal Skin
(4) IL-1a levels Condition Score
(corneocytes showed no
collected with significant difference
Sebutapes, between skin
IL-1a assay) care groups
Assessments on (data not shown)
days 2, 14, and (5) Prevalence
28 postpartum of DD on
(5) Microbiologic day 28:
colonization at 10% in each group
baseline and day 28

Primary variables are marked in bold.


DD, diaper dermatitis; SCH, stratum corneum hydration; TEWL, transepidermal water loss; IL, interleukin.
Blume-Peytavi et al: Prevention of Diaper Dermatitis
419

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TABLE 2. Evidence of Effects of Bathing on the Diapered Area in Infants
Study endpoints;
assessment
Study Level of Sample and timepoints
Author Topic design Duration Intervention evidence group sizes Age and sites Results Remarks

Visscher Effect of bathing Prospective, 1-day assessment III 52 infants 3–6 months (1) TEWL (Servo Effect of bathing
et al (26) in water plus descriptive (immediately Med EPI (before vs after bath)
Johnson & Johnson study after removing evaporimeter) in diapered region:
Baby Bath on the diaper and (2) SCH and (1) TEWL 2 min
diapered skin again MAT (NOVA after diaper removal:
after overnight immediately Dermal Phase 28.3  2.1 vs
diaper removal after bathing) Meter) 28.9  1.5 (p = 0.8);
(subgroup analysis) (3) Skin friction TEWL 17 min after
(skin surface diaper removal:
friction meter) 14.4  0.7 vs
(4) Erythema 14.7  1.0
and dryness (p = 0.75);
on 7-point (2a) Hydration
scale (0 = no 2 min after diaper
erythema removal: 198  17 vs
to 3 = high, 174  17 (p = 0.13);
in 0.5 increments) 17 min later: 108  2.1
(5) Spectrophotometer vs 107  2.6 (p = 0.63)
(Datacolor) (2b) MAT 2 min after
(6) Image analyzing diaper removal:
by mothers using 9.0  0.8 vs 8.4  0.7
420 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

Adobe Photoshop (p = 0.53); 17 min


and Microflash later: 3.0  0.3 vs
(images of buttocks 1.7  0.3 (p = 0.001);
and perineum a (3) Skin friction after
visual perception 16 min: 30.4  4.8
system for imaging vs 7.4  2.3 (p < 0.001)
infant skin (Translite (4a) Erythema grade
nevoscope coupled after 3 min:
to high-resolution 0.7  0.07 vs
digital camera) 0.3  0.04 (p < 0.001)
Assessments: 2 min (4b) Dryness grade
or up to 19 min after after 3 min: 0.2  0.04
overnight diaper vs 0.05  0.02 (p < 0.001)
removal and after (5) Skin color after 4 min:
subsequent bathing lightness: 145.2  3.0
vs 147.0  3.1 (p = 0.35),
after 19 min: lightness:
70.4  0.8 vs 70.6  0.8
(p = 0.38)
(6) Buttock before vs
after bath: 1.2
(p = 0.01);
perianal region before
vs after bath: 1.0
(p = 0.01)
Garcia Bartels Comparison of Prospective, 8 weeks Infants received II 64 infants: Neonates (1) TEWL (Tewameter Values on buttock Parents
et al (32) bathing in randomized, skin care regimens 16 infants <48 hours TM 300) at week 8: were
pure water parallel-group, twice per week per group (2) SCH (corneometer (1) TEWL: control allowed
(control) vs four-arm study CM 825) 8.0 vs wash gel to treat

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TABLE 2. Continued
Study endpoints;
assessment
Study Level of Sample and timepoints
Author Topic design Duration Intervention evidence group sizes Age and sites Results Remarks

bathing with from day 7 until (3) Skin pH (skin pH 8.0 (p > 0.05) incident
wash gel on week 8 of life meter 905) (2) SCH: control 55.6 DD with
skin barrier (4) Sebum content vs wash gel 57.7; (p > 0.05) zinc
function (sebumeter SM 815). (3) Skin pH: control 5.22 paste
All instruments from vs wash gel 5.0 (p < 0.001); (optional
Courage & Khazaka, (numbers 1, 2, and 3: with
Germany (multiprobe approximate values nystatin)
adapter system) extracted from graphs)
(5) Skin condition (4) Sebum: no single
according to NSCS values for buttock
(dryness, erythema, region shown
excoriation on 3-point (5) NSCS and DD:
scale each) and DD buttocks area never
frequency affected by DD
Assessments at 4 sites (only perianeal);
(forehead, abdomen, frequency of DD
upper leg and buttock) overall very low,
on day 2 and weeks 2, 4 DD in week 8:
and 8 postpartum; all control 1/16
measurements done (6.3%) vs wash
12 hours after last gel 0/16 (0%)
application

Primary variables are marked in bold.


NSCS, Neonatal Skin Condition Score; MAT, moisture accumulation rate; SCH, stratum corneum hydration; TEWL, transepidermal water loss.
Blume-Peytavi et al: Prevention of Diaper Dermatitis
421

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TABLE 3. Evidence of Effects of Skin Care on the Diapered Area in Infants: Topical Skin Products
Study endpoints;
assessment
Study Level of Sample and timepoints and
Author Topic design Duration Intervention evidence group sizes Age sites Results Remarks

Bosch- Comparison of Prospective, 12 weeks Daily application II 114 infants: Newborns DD severity on Mean DD
Banyeras vitamin A cream randomized, of creams after vitamin A (assumed 5-point scale severity
et al (33) with control cream; double-blind, each diaper cream (n = 58), from study (0 = absent to scores during
vitamin A cream: parallel-group, change for control cream protocol) 4 = severe six follow-up
Lassar’s plain zinc two-arm study 12 weeks (n = 56) erythema, visits: 0.3  0.4
paste (30 g), lanolin swelling, in vitamin A
(20 g), petrolatum multiple lesions) group vs
(10 g), vitamin A Assessments 0.2  0.3 in
ester palmitate every 15 days control group
(1,000 IU/g); for six follow-up (ns)
control cream: visits Incidence DD
same components at baseline vs
except vitamin A week 12:
vitamin A
group 29/58
(50%) vs 1/58
422 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

(1.7%), control
34/56 (60.7) vs
1/56 (1.8%)
Muggli Comparison of Prospective, 8 weeks Use of test or IV 66 infants: 2 weeks to (1) Erythema No significant No baseline
et al (34) evening primrose randomized, comparator group size 6 months on 3-point differences in data reported;
oil (Efamol, Riegel open-label, cream for not reported scale (1–3) probability on randomization
quality) with parallel-group, 8 weeks; (2) Skin rash time-to-event unclear; no
commercial two-arm study assement by on 4-point curves and in absolute
cream (Penaten) caregivers scale (1–4) mean total values reported
using diary (3) Skin dryness scores between
on 4-point groups for
scale (1–4); erythema, skin
assessments: rash, or skin
dermatological dryness
examination by Medically
clinical staff and diagnosed DD
questionnaires not observed in
filled out by either group
caregivers at
baseline,
days 28 and 58.
Garcia Bartels Comparison of Prospective, 8 weeks Infants received II 64 infants: Neonates (1) TEWL Values on No special
et al (32) application of randomized, one of 4 skin 16 infants <48 hours (2) SCH buttock diaper cream
baby cream after care regimens per group (3) Skin pH at week 8: used; parents

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TABLE 3. Continued
Study endpoints;
assessment
Study Level of Sample and timepoints and
Author Topic design Duration Intervention evidence group sizes Age sites Results Remarks

bathing vs bathing parallel-group, twice per week (4) Sebum (1) TEWL: allowed to
in water only or in four-arm study from day content control 8.0 vs treat incident
water and wash gel 7 until week (5) NSCS cream 7.6 (p = 0.01) DD with zinc
Control: bathing 8 of life and frequency (2) SCH: control paste (optional
in water only of DD 55.6 vs C 55.6; with nystatin)
Cream: bathing in (6) Microbiological (p > 0.05)
water and colonization; (3) Skin pH
cream afterwards assessments at control 5.2 vs
(Baby Caring four sites (forehead, cream 5.2; (numbers
Facial & Body abdomen, upper 1, 2, and 3:
Cream, Penaten) leg and buttock) approximate
Wash gel plus cream: on day 2 and weeks values extracted
bathing with wash 2, 4, and 8 from the graphs)
gel plus cream postpartum; (4) Sebum: no
all measurements single values for
taken 12 hours buttock region
after last shown
application (5) DD: buttocks
area never
affected by DD
(only perianeal);
frequency of
DD overall very
low; DD in week
8: Control 1/16
(6.3%), cream
2/16 (12.5%);
(6) Microbiology
at umbilicus
at week 4: no
Candida
colonization;
bacterial
colonization
present in all
groups, control
9 vs cream 10
(p > 0.75)

Primary variables are marked in bold.


DD, diaper dermatitis; NSCS, neonatal skin condition score; SCH, stratum corneum hydration; TEWL, transepidermal water loss.
Blume-Peytavi et al: Prevention of Diaper Dermatitis
423

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424 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

severity of erythema (24) or diaper rash (23) were study of Odio et al (24) had a methodological quality,
observed in the water-and-washcloth group in the but the treatment period was short (1 week). Skin
perianal or intertriginous areas (23,24). The use of roughness was assessed in 24 of 41 subjects per group,
washcloths resulted in a greater increase in skin but no reason for this selection process was given. The
roughness in microtopography than the use of baby study of Senses et al (31) had a limited design without
wipes (24). In a large study of 280 newborns, randomization and blinding and lacked information
Lavender et al (25) found no difference in DD severity on the duration of treatment. Adam et al (30)
between the groups after 4 weeks as reported by provided no details on study design, such as random-
midwives. In another study, the prevalence of DD in ization, blinding procedures, and group size, and the
44 newborns on day 28 did not differ between two age of the subjects was not mentioned, but the term
groups using baby wipes or a water-moistened wash- “infants” suggests an age of 1 to 24 months. No
cloth for cleansing the diaper area for 4 weeks in absolute skin pH values were reported.
healthy newborns (29). Comparing four different wipe In the RCT of Lavender et al (25), DD was not a
brands differing in lotion ingredients and pH, Priest- primary outcome variable. The mothers’ assessment
ley et al (28) found no difference in DD severity after over time (diary records) favored wipes over water.
8 weeks of application. Because the mothers were not blinded, this could have
Adam et al (30) found that a single cleansing led to selective reporting in either direction. A
procedure with different treatments such as soap, significant difference in diaper change frequency was
detergent, wipes, and water had a direct effect on the detected, with diapers being changed more often in the
skin surface pH. In a second study they showed that wipes group. Another RCT comparing wet wipes with
cleansing of the diaper area with a test wipe for water by Garcia Bartels et al (29) included few
2 weeks increased the skin surface pH significantly subjects, which might have limited the ability to
less than cleansing with water and washcloths (30). observe clinically important differences between treat-
When wipes containing lotions with different pH were ments.
compared, the resulting skin pH differed significantly Because of possible study bias (no randomization
between the wipe brand with the lowest pH and other details described, use of ointment ad libitum allowed,
test wipes (28). Overall skin pH values remained in the malfunction of the pH meter described), the results of
ranges found in healthy infant skin (6,26,28). In Priestley et al (28) must be interpreted with caution.
neonates, the skin pH decreased over the first 4 weeks
of life, independent of the cleansing practice with
Effect of Bathing
wipes or water and washcloth (29). After 4 weeks,
both treatments resulted in similar skin pH values Two studies were identified that analyzed the effects of
within the physiologic range (25,29). bathing with water or with additional washing agents
In a study with 44 neonates, significantly lower (baby wash gel) on functional skin parameters (Table
TEWL levels were found on the buttocks of the wipe 2).
group than in the water group after a 4-week In a 1-day observation, Visscher et al (26) compared
treatment phase (29), but TEWL rates were similar the biophysical properties of nondiapered and dia-
between the wipes and water groups in two other pered infant skin in 52 infants ages 3 to 6 months
studies with neonates (25) and infants approximately before and immediately after bathing. They found that
15 months old (24). Cleansing with baby wipes or overnight occlusion significantly altered diapered skin,
water had comparable effects on the stratum corneum with higher skin erythema values and coefficients of
hydration of neonates (25,29). Neither skin cleansing friction, TEWL, surface hydration, MAT, and skin
regime affected microbiologic colonization of the color (digital imaging and spectrophotometry). In
perianal region by Coliform bacteria or Candida addition to an overall clinical assessment, diapered
(25,31). skin was assessed by grading erythema. Bathing in
fresh water (with additional baby bath as preferred)
Study Limitations Ehretsmann et al (23) assessed the directly after diaper removal for 10 minutes led to
status of skin irritation using a diaper rash and lower erythema, skin friction, and dryness, reaching
erythema scoring scale over a 2-week period. Data the level of nondiapered skin. High TEWL and
were presented as average diaper rash scores and baseline hydration decreased to normal levels over
diaper rash time curves, allowing good estimation of time, and the bathing procedure did not influence this.
DD scores, but information on randomization, group Garcia Bartels et al (32) assessed the long-term
size, and baseline data of subjects was missing. The effects of bathing with water and wash gel on skin
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Blume-Peytavi et al: Prevention of Diaper Dermatitis 425

barrier function in a prospective study with 64 information about baseline data, randomization pro-
neonates over their first 8 weeks of life. The infants cedures, or absolute values, limiting the interpretabil-
received four different skin care procedures twice ity of results. The study of Garcia Bartels et al (32)
weekly: they were bathed in clear water only or with reports on a high-quality RCT, but the small number
wash gel added and subsequently received baby cream of subjects per group could have limited the ability to
or no cream. Skin condition was measured according detect differences between treatment groups.
to the Neonatal Skin Condition Score and DD was
assessed according to clinical scoring and frequencies
of DD. In the study arms comparing bathing with and DISCUSSION
without wash gel, the incidence of DD during the
Etiology of DD and Skin Barrier Dysfunction
study period was low (0–12.5%) and was unaffected
by the cleansing additive. After 8 weeks, skin pH at all Diapered skin in nonlesional sites is significantly
sites including the buttocks differed significantly different from nondiapered skin with signs of com-
between the wash gel and water-only groups, but the promised skin barrier function such as TEWL, skin
cleansing product did not alter other skin variables. surface hydration, MAT, and skin surface pH
(8,26,35). To protect diapered skin and to prevent
Study Limitations The study of Visscher et al (26) the onset of DD, skin care practices should be used
assessed the short-term effects (within 20 minutes that support skin barrier function, keep the buttocks
after bathing) of a single cleansing procedure. Because skin dry, protect it from feces and urine, reduce
bathing was performed in water and additional baby additional friction (e.g., through gentle cleansing
bath additives, the results must be interpreted as an procedures), limit exposure to irritants, and stabilize
effect of bathing itself and bath additives. the skin surface pH in the diaper area (6,8,17).

Effect of Topical Skin Products Summary of Evidence and Critical Appraisal


We identified three studies analyzing the influence of Six RCTs (LoE II), three nonrandomized trials (LoE
different diaper care regimens, such as diaper oint- III), and four studies (LoE IV) analyzed the effective-
ments, oils, and baby creams, on the incidence and ness of cleansing, bathing, and the application of
severity of DD and on skin function (Table 3). The topical products in the prevention of DD or the
duration of treatments varied between 8 and maintenance of healthy skin in the diaper area. The
12 weeks. Two of the trials compared a vitamin A– available clinical evidence can be summarized as
containing ointment (33) or evening primrose oil (34) follows.
with a standard ointment. Garcia Bartels et al (32)
compared regular application of a baby cream in Cleansing Procedures Although prevention of DD
addition to bathing with bathing alone. Two studies was not the primary goal of the eight studies on
were performed in neonates (32,33) and one in infants cleansing procedures, there is good evidence to
ages 2 weeks to 11 months (34). conclude that cleansing with baby wipes has an effect
No differences in DD severity scores were found on the incidence and severity of DD equivalent to that
between vitamin A ointment or evening primrose oil of water and washcloth (23 [LoE III], 24 [LoE II],
and usual diaper ointment (33,34). Application of 25 [LoE II], 28 [LoE III], 29 [LoE II]).
baby cream two times per week after bathing did not There is limited evidence from single studies that
alter DD frequency but slightly decreased TEWL baby wipes seem to be milder to the skin than water
values over the 8-week treatment period (32). This and washcloth, as DD (23 [LoE III], 24 [LoE II], 25
skin care routine did not alter SCH or skin pH. In two [LoE II]) and skin roughness (24 [LoE II]) scores were
studies, DD severity scores were low during and at the slightly but significantly lower with wipes, although
end of the treatments (32,33). The study of Bosch- various wipes with different formulations were used in
Banyeras et al (33) reported a dramatic decrease in the reviewed trials and absolute differences in DD and
DD incidence, from 50% or more at baseline to 2% at skin roughness scores between the treatment groups
week 12 in both treatment groups. were low and might not be clinically relevant. There-
fore we cannot conclude from the data that one
Study Limitations The study of Bosch-Banyeras et al treatment is more effective than another.
(33) was of high quality regarding its design and There is convincing evidence that the different
reporting. The study of Muggli et al (34) contains no cleansing procedures do not clinically affect skin
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426 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

function as assessed by skin pH, SCH, TEWL, and Water, as a traditional cleansing method, has some
microbial and Candida colonization (25 [LoE II], 29 disadvantages. Cleansing of soiled skin with water
[LoE II], 30 [LoE IV], 31 [LoE IV]). Whether the use alone requires more rubbing, because water-insoluble
of different types of wipes with lotions with different residues of feces may not be removed efficiently.
pH can influence skin pH is unclear and open to Furthermore, tap water has a pH of 7.9 to 8.2, which
further investigation, as good RCTs are missing (28 could affect the pH of the skin (25). In the case of hard
[LoE III], 30 [LoE IV]). There is limited evidence from tap water, precipitates can be formed and dry the skin
one trial that skin care with specific wipes, which leave even further (43).
a protective lipid layer on the skin, leads to lower The evidence presented here suggests that the use of
TEWL than the use of water in neonates (29 [LoE II]). baby wipes is tolerated at least as well as water and
washcloth. There were no clinically important differ-
Bathing Procedures Skin condition and DD severity ences in the severity and incidence of DD and
were assessed in two studies on bathing procedures. erythema or in SCH, TEWL, and skin pH.
There is evidence from one study that bathing twice One study found that a single bath might reduce
a week with pure water has effects on skin condition diaper-induced erythema and dryness (26 [LoE II]). It
and DD frequency in the diaper area in neonates has been reported that bathing twice a week does not
comparable to those of washing with water and wash negatively influence skin barrier development in
gel (32 [LoE II]). A reduction in skin pH after 8 weeks neonates, but reduced TEWL levels on the buttocks
of bathing with wash gel was detected, although the (38). The addition of a wash gel to this routine bathing
effect was small and not clinically relevant. procedure does not further ameliorate skin function
One trial suggested that a single bath (with Baby or affect DD incidence, as Garcia Bartels et al showed
Bath) can reduce diaper-induced erythema, skin (32). TEWL on the buttocks was low under both
friction, and dryness (26 [LoE III]). conditions at the end of treatment and was not
affected by adding the wash gel, although the use of
Topical Skin Products In two of the three trials, wash gel had the potential to reduce skin pH on the
prevention of DD was the primary goal. buttocks after 8 weeks of treatment. Higher skin pH is
There is no evidence that the addition of vitamin A generally associated with greater skin hydration and
to standard ointments or primrose oil is more effective higher diaper rash scores (39). A reduction of skin pH
than the use of standard ointments alone in prevent- or maintenance of the acidic milieu in the diaper area
ing DD in infants (33 [LoE II], 34 [LoE IV]). It is could therefore be an important step in the prevention
difficult to make a conclusion regarding the preventive of DD.
effect of active vitamin A or primrose oil and control Experts recommend the application of topical prod-
ointments. First, both trials lacked a study arm with ucts containing zinc oxide, petrolatum (8,12,13,15,16),
no treatment, and second, we found no published or cod liver oil (12) and claim that they are effective in
RCTs analyzing the effect on DD prevention of either DD prevention and treatment. One of the first DD
of the standard ointments, although Bosch-Banyeras studies on petrolatum was published in 1988 (40), but
et al (33) reported a large decrease in DD incidence, there have been few published controlled trials ana-
from 50% or more at baseline to approximately 2% lyzing the efficacy of topical products in DD. Rowe
with active vitamin A or primrose oil and control et al (18) found some adequately controlled clinical
ointment after 12 weeks of treatment. This effect trials that proved the effectiveness of zinc oxide and
could be interpreted as a preventive effect of the zinc petrolatum in DD treatment, but none was found that
oxide–containing standard ointment or enhanced proved effectiveness in DD prevention. We found no
parent education. study comparing a topical preparation with no
Application of baby cream twice weekly after treatment, but found two trials analyzing the pre-
bathing does not result in a change in DD incidence ventive effect of the addition of vitamin A or primrose
compared with no treatment (32 [LoE II]), but it could oil to standard barrier preparations (33,34). Both
positively influence barrier functions of healthy skin study treatments were at least as effective as controls.
by reducing TEWL. Barrier preparations should work by protecting the
Baby wipes as cleansers have become more and skin from fecal contact and may provide some
more common (24) because they are effective and easy protection from wetness (18). Higher SCH values
to use, although baby wipe–induced dermatitis in are found on diapered versus nondiapered skin
adults has been described (36,37), causing some health (5,25,29), and overhydration of diapered skin is sup-
professionals to encourage the use of water only (21). posed to be an aggravating factor in the development
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Blume-Peytavi et al: Prevention of Diaper Dermatitis 427

of DD (39). The application of a whole-body baby What is Effective for Prevention? Implications for
cream after a regular bath two times per week did not Practice
alter DD incidence or influence SCH scores, but
To prevent DD, experts generally recommend mini-
reduced TEWL levels. Because the cream was not
mizing diaper wearing time; changing diapers fre-
specially designed for the diaper region, and DD
quently; using disposable, superabsorbent, breathable
prevention was not the primary objective of this
diapers; bathing at least daily in water with baby oil or
study, the effect of this baby cream could not be
water-dispersible creams; cleansing gently; and apply-
properly evaluated.
ing protective ointments and pastes that are petrola-
tum based or contain substances such as zinc oxide
Limitations of This Review (8,12,13,15,16).
The evidence derived from our review supports
Our review and the included studies have several
that baby wipes or water and washcloth can be used
limitations. First, the quality of the studies varied
for cleansing of the diaper area. There is convincing
considerably. Only 6 of 13 trials were RCTs, and
evidence that both procedures have comparable
study details and results were not always properly
effects on diapered skin and maintain the skin barrier
reported. The small sample size of most studies (<50
equally.
participants per group) could have led to underesti-
There is no clear evidence that baby wipes in
mation of treatment differences. Second, the safety
general are more gentle cleansers than water and
and tolerability aspects of treatments but not DD
washcloth. Results from single studies show that
prevention were the primary outcome parameters of
cleansing with wipes produced slightly lower levels of
most trials. In general, the heterogeneity of outcome
DD and erythema and lower TEWL, but because of
measures was high, ranging from the severity of DD
study limitations and the large number of commer-
and erythema to the DD incidence at different time
cially available wipes, differing in ingredients and pH
points. In addition, because the DD incidence was
values, a favorable effect of wipes over water and
low, the effects of different treatments could have been
washcloth cannot be determined.
masked. The marked difference in DD prevalence
Our review confirms the recommendation of
between real-world settings of up to 50% (6) and
experts to bathe for cleansing twice a week
clinical studies of approximately 10% to 15% is a
(15,41,42). There is limited evidence from our review
point for further investigation. In addition, only a few
that specific skin function parameters such as skin
studies assessed all relevant skin function parameters.
surface pH and TEWL can be reduced by adding a
This heterogeneity limited the interpretability of the
mild washing agent such as baby cleanser and
efficacy data.
applying baby cream after bathing, respectively.
Our search was restricted to studies in English or
Barrier preparations containing zinc oxide or petro-
German published in the databases Medline and
latum, usually recommended by experts, seem to
Embase, and we did not conduct an explicit search for
protect the skin from wetness and may help reduce the
grey literature (e.g., unpublished studies, studies in
severity of DD (18). We found no trials comparing
press or progress), so we could have missed valuable
topical agents for DD prevention with no treatment,but
studies. To search for additional studies we screened
two trials compared vitamin A and primrose oil with
the reference lists of all publications selected from the
standard ointment. Both treatments were similarly
searches described above, thereby identifying one
effective in the prevention of DD as control ointments.
study published in French, but it was excluded
There is no clear published evidence whether skin
because of language restrictions. Nevertheless, a
practices such as cleansing, bathing, and application
comprehensive search on barrier preparations per-
of topical preparations can prevent DD. There is
formed by Rowe et al (18) and recently published
limited evidence that these practices favorably influ-
guidelines on neonatal skin care (15) did not retrieve
ence specific physiologic skin parameters involved in
further studies on the prevention of DD. Because our
supporting proper skin function in the diaper area.
search was performed for the period from 1970 to July
Further studies are needed to show their effectiveness
2012, recently published studies could have been
on a clinical level.
missed, making a future update necessary. Finally, we
Overall, the lack of RCTs with reliable outcome
performed no formal quality assessment of the
variables such as DD grading, DD incidence, and
included studies, but LoEs according to the Oxford
standardized skin function parameters limits the
Centre for Evidence-Based Medicine were assigned to
interpretability of the results.
all individual studies.
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428 Pediatric Dermatology Vol. 31 No. 4 July/August 2014

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