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[Treatment of atopic dermatitis with oxatomide oral suspension (2.5 mg/ml) in infants]
1Divisione Pediatrica, Ospedali Riuniti, Bergamo.
Insights
Oxatomide, an antiallergic drug, effectively and safely treats atopic dermatitis in children under 2 years old. Both tested low-dosage regimens showed significant symptom reduction within 60 days.
Area of Science:
- Pediatric Dermatology
- Allergy and Immunology
- Clinical Pharmacology
Background:
- Atopic dermatitis is a common skin condition in infants.
- Effective and safe treatments for young children are crucial.
- Oxatomide is a known antiallergic medication.
Purpose of the Study:
- To evaluate the efficacy and safety of oxatomide in children under 2 years with atopic dermatitis.
- To compare two different low-dose administration schedules of oxatomide.
Main Methods:
- A 60-day trial involving 20 children under 2 years old.
- Administration of oxatomide oral suspension (2.5 mg/mL) at 1 mg/kg/day (single evening dose) or 0.5 mg/kg every 12 hours.
- Assessment of cutaneous symptoms and adverse events at regular intervals.
Main Results:
- Significant reduction in atopic dermatitis symptoms, including itching and crusting, after 15 days.
- Erythema and papulovesicles improved by day 30.
- Both dosage regimens were effective and safe, with a single evening dose showing slightly faster improvement.
Conclusions:
- Low-dose oxatomide is an effective and safe antiallergic treatment for infants with atopic dermatitis.
- The drug is well-tolerated in this sensitive pediatric population.
- Further research may explore optimal dosing strategies.
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.