Background: This study was designed to assess the efficacy and safety of oxatomide oral suspension, in breast-fed and young babies with atopic dermatitis.
Methods: Thirty-one children (11 females, 20 males) aged between 4 and 35 months (mean+/- SD 15.4+/-7.6 months) were treated with oxatomide (2.5 mg/mL) at a dose of 1 mg/kg/day) split into two doses, every 12 hrs; treatment lasted 30 days. Efficacy was evaluated on the basis of the following signs and symptoms: itching (severity, extension and duration), blisters (number, extension), erythema (severity, extension), papules (number, extension), lesions from scratching (yes/no), dry skin (yes/no).
Results: Skin signs improved significantly with oxatomide. Itching was reduced 58.2% from baseline, and erythema 57.6% (both p<0.001). Vesicles, papules, lesions due to scratching and dry skin also improved significantly. Oxatomide had to be stopped only in one child in whom the dermatitis became worse.
Conclusions: These results show the efficacy and safety of oxatomide in breast-fed or very young babies with atopic dermatitis. The oral suspension was particularly easy to use in children less than two years old, on account of the simple dosage schedule.