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S Tripodi,1 A Di Rienzo
Businco,1 V Panetta,2 G Pingitore,3
A Volterrani,4 T Frediani,5 S
Pelosi,6 S Miceli Sopo7 |
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1 Pediatric Allergology Unit, S.
Pertini Hospital,Rome, Italy
2 Medical Statistics & Information Technology, AFaR,
Fatebenefratelli Association for Research, Isola
Tiberina, Rome, Italy
3 Pediatric Department G.B. Grassi Hospital, Rome,
Italy
4 Allergology Unit, Nuova Regina Margherita Hospital,
Rome, Italy
5 Pediatric Department, La Sapienza University, Rome,
Italy
6 TPS production, Rome, Italy
7 Pediatric Department, A. Gemelli Hospital, Rome,
Italy |
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Abstract |
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Introduction:
Atopic dermatitis is
a common disease in
children. It is
usually treated with
topical steroids
and/or calcineurin
inhibitors in
association with
emollients but
topical antioxidants
have been recently
introduced as a
therapeutic option
for children. The
aim of this study
was to evaluate the
efficacy and
tolerability of
furfuryl palmitate,
a new antioxidant
molecule, in a
multicenter,
randomized,
doubleblind,
vehicle-controlled
study.
Patients and
Methods:
Children with atopic
dermatitis were
randomized into 2
groups treated for 2
weeks. One group of
children (n=60) was
treated with a basic
emollient cream and
the other (n=57) was
treated with the
same cream enriched
with furfuryl
palmitate.
Results: In
both groups, there
was a signifi cant
reduction (P<.001)
in atopic
dermatitismeasured
using the SCORAD
indexafter 14 days.
The reduction in the
per-protocol
analysis was higher
for the basic cream.
Treatment success
was defined as a
reduction of 20% or
more in the SCORAD
index from baseline
to day 14. Patients
who used treatment
not permitted by the
protocol were also
considered treatment
failures. The
intention-to-treat
analysis showed 70%
positive results for
the basic treatment
and 29% for the
treatment containing
furfuryl palmitate
(P<.0001) with a
number needed to
treat of 2.4 (95%
confidence interval,
1.6-4.6). The
emollient cream
without furfuryl
palmitate was
observed to be more
efficacious by
pediatricians and
parents, and no
differences were
reported between the
2 products in terms
of tolerability.
Conclusions:
Both products proved
to be efficacious in
treating atopic
dermatitis in
children, but the
emollient cream not
containing furfuryl
palmitate showed
better clinical
efficacy.
Key words:
Atopic dermatitis.
Children. Furfuryl
palmitate. Topical
administration.
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