Abstract
In order to find optimal doses of E-0659 (azelastine hydrochloride) for infants and children with atopic dermatitis a multicenter study was carried out by the double-blind method. The subjects admitted to the study were divided into three dose groups which received E-0659 at doses of 0.017, 0.07 and 0.13 mg/kg/day, respectively.
1. Of 183 subjects admitted to the study, 157 were chosen for general improvement rating (GIR), 168 for overall safety rating (OSR) and 159 for general usefulness rating (GUR) assessment.
2. There was no significant difference in GIR, OSR or GUR among the three dose groups.
3. Sixty-seven patients who took the test medication as prescribed for 4 weeks showed an improvement ratio in FGIR higher in H group (68.2%) than in M (47.4%) or L (45.5%) group although it was nor significantly different. A significant difference in improvement ratio was found among the three groups after 2 weeks in GIR. In the symptoms such as itching, papula and erythema a significant difference in improvement was observed among the three groups.
