[Treatment of atopic dermatitis with oxatomide oral suspension (2.5 mg/ml) in infants].

BACKGROUND

The aim of the present trial is to determine the efficacy and safety profile of oxatomide, a potent antiallergic drug, in children aged under 2 years, suffering from atopic dermatitis. A comparison between 2 different dosage schemes was scheduled.

METHODS

An oral suspension of oxatomide, in a neonatological formulation at a low dosage (2.5 mg/mL) was administered to 20 children in the following manner: 1 mg/kg/day in a single evening dose (9); 0.5 mg/kg every 12 hrs (11) for a period of 60 days. Cutaneous symptoms were assessed at the baseline, and after 15, 30 and 60 days. All adverse events were recorded in detail.

RESULTS

After 15 days, at both doses, oxatomide significantly reduced (p < 0.05 vs baseline) atopical symptoms: itching, crusting, lesions due to scratching and after 30 days erythema and papulovesicles. No statistically significant differences were observed in terms of efficacy between the two dosage schemes, although oxatomide in a single dose led to a slightly faster improvement. Oxatomide displayed an excellent therapeutic safety profile.

CONCLUSIONS

The results show that oxatomide in a low-dosage formulation is a good antiallergic drug, effective and safe in a specific population which is extremely delicate, such as children under 2 years old.