The Nutrition & Hygiene Company
MEDICAL UPDATES
VOL. 1 Series No. MU005-2011
A Randomized Controlled Trial On The Efficacy Of
Zinc Oxide Versus Zinc Oxide With Allantoin In
The Treatment Of Irritant Contact Diaper
Dermatitis
Hazel A. Villaluz,MD, Ma. Lucila M. Perez MD,
Nepthalie R. Ordonez MD, Lourdes L. Balcueva MD,
Department of Pediatrics-2002
ABSTRACT
BACKGROUND:
Diaper dermatitis is the
most common dermatologic disorder of infancy,
with 7 to 35% of infants in diapers affected1,
with the highest prevalence occurring between 9
to 12 months of age⁹. It accounts for about 97
doctor visits per 1000 infants in 0-2 years of
age group, according to National Survey of
Medicine 13, and Pediatricians
provide 75% if services for the treatment.3
It is condition caused by
the combination of wearing diapers, and
incontinence of urine and feces. The available
evidence suggests that maceration of the stratum
corneum by the water increases susceptibility to
frictional damage, and epidermal permeation of
irritants.2
Other
risk factors identified are: nutritional factor
and diaper factor.
Breastfeed infants have less frequent diaper
rash than those who are bottle fed. Solid foods
decreases stool frequency, thus decreasing
frequency of diaper eruptions.
Protecting the skin in the diaper area is of
great benefit in all forms of diaper dermatitis.
Advances in different aspects of technology have
been directed towards the prevention and
treatment of diaper dermatitis. Pharmaceuticals
have designed diapers that deliver
dermatological formulations to help protect skin
from over hydration and irritation.
Zinc oxide pastes are excellent in preventing
diaper dermatitis. Some pharmaceuticals have
added substances like allantoin to the usual
zinc oxide paste to hasten its effect. Allantoin
is said to be proliferant, an epithelialisation
stimulant, and a chemical debrider. It is used
in
skin cosmetics, as well as in other products
like shampoo, lotion, etch.
Many topical agents were made available to the
market for treatment of the skin lesions. It
would very helpful for the physicians to know if
the new topical agents will be comparable if not
more effective than the most frequently used
ones today.
OBJECTIVE:
To compare the efficacy of Zinc Oxide combined
with Allantoin against pure Zinc Oxide for the
treatment of uncomplicated diaper dermatitis
among infants.
STUDY DESIGN AND SETTING:
Randomized Double Blind Controlled Clinical
Trial in a tertiary private hospital.
SUBJECTS:
Patients admitted at MCU Department of
Pediatrics and those seen as outpatient whose
ages ranges from 0-24 months old diagnosed with
uncomplicated diaper dermatitis (absence of
violaceous plaque and nodules as seen in
granuloma gluteale infantum; without fungal
invasion).
METHODOLOGY:
Patients who had eruptions in the diaper area
were recruited and were classified according to
severity: mild diaper dermatitis – with
erythematous macules and patches with or without
scales; moderate DD – with erythematous patches
with micropapules and superficial macerations
and severe DD – erythematous patches with
erosions or ulcers that are well demarcated and
punched out with slightly elevated borders.
All patients eligible for the study had KOH
examinations of the skin at the diaper area to
note for the presence of any spores or hyphae
indicating the presence of fungi. The swabbing
was done by principal investigator and the KOH
examinations were done by the medical
technologist. Those who are KOH (+) were
excluded and those were KOH (-) were included.
Parental informed consent were obtained.
Data in the history such as sex, age, and with
or without diarrhea, the duration of the diaper
dermatitis, and the character of rash were
described. Diapering strategies as to the type
of diaper used and frequency in the change of
the diaper were noted. Maternal factors
such
as maternal age, educational attainment, etch
were also documented.
Randomization using the table of random numbers
was done with the help of another individual who
was also the one who
distributed the products to be tested.
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