Efficacy and tolerability of a cream containing AR-GG27® (sorbityl furfural
palmitate) in the treatment of mild/moderate childhood atopic dermatitis
associated with pityriasis alba. A double-blind, placebo-controlled clinical
trial.
Author(s): Patrizi A, Raone B, Raboni R, Neri I.
Affiliation(s): Department of Internal Medicine, Aging and Nephrology, Policlinico S. Orsola
Malpighi, Bologna, Italy. annalisa.patrizi@unibo.it
Publication date & source: 2012, G Ital Dermatol Venereol. , 147(6 Suppl 1):1-8
AIM: Pityriasis alba (PA) is a skin disorder characterized by finely scaly,
hypopigmented patches, typical of childhood, that also represents an atopic
dermatitis (AD) minor sign according to Hanifin and Rajka criteria. It may be
isolated or associated with AD representing, sometimes an atypical manifestation
of AD during the long-term follow-up of the disease. Aim of the study was to
evaluate of the efficacy and tolerability of AR-GG27® (sorbityl furfural
palmitate) cream in the treatment of childhood mild or moderate AD associated
with PA.
METHODS: The trial is a single center, double-blind, randomized,
placebo-controlled study. The study included patients of both sexes, aged between
two months and 15 years, suffering from mild and moderate AD always associated
with PA. Xerosis was present in all patients. The treatment with topical steroids
or topical calcineurin inhibitors (TIMs) had to be suspended for at least 15
days. Any systemic therapy and phototherapy or sun exposure were withdrawn at
least 30 days before. Emollients were stopped at least seven days before. During
the trial, no other local or systemic treatments were allowed, as well as sun
exposure. Patients affected by AD with viral, bacterial or fungal overinfection
or patients with diabetes mellitus, severe systemic diseases or intolerance to
one or more components of the product were excluded. The primary endpoint was the
evaluation of the average change in the Investigator Global Assessment (IGA)
after 15 and 30 days of treatment. The second endpoint was the evaluation of
severity of three different clinical signs: erythema, excoriation desquamation,
using a subjective five-point scale. Changes in pruritus severity was also
considered during the entire period of treatment, through the use of a Visual
Analogue Scale (VAS). A P<0.05, two tailed was considered as statistically
significant.
RESULTS: After 15 and 30 days there was a statistically significant difference in
the group treated with AR-GG27®, compared to the placebo (respectively, P=0.0007
and P=0.005). After 15 days of treatment, itching was clearly reduced in AR-GG27®
treated group compared with the placebo, both in the study population (P=0.01)
and in patients where the symptom was present from the beginning (P=0.05).
CONCLUSION: AR-GG27® showed a beneficial action associated with high compliance
and tolerability in dermatological skin conditions characterized by inflammation
and tissue oxidative stress in children, as PA with mild and moderate AD.
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