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.

OBJECTIVE

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 Any systemic therapy and phototherapy or sun exposure were withdrawn at least 30 days before.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).

CONCLUSIONS

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.