@entity1499 treatment in juvenile XXXX : a randomized, double-blind, placebo-controlled trial.

@entity1 @entity75 @entity229 @entity2631 @entity2319 @entity1500 @entity74 @entity1499 @entity54909
OBJECTIVE: Juvenile @entity2631 is a chronic progressive @entity74 of the skin that causes @entity2319 and aesthetic damage. This study was undertaken to assess the safety and efficacy of @entity1499 ( @entity1500 ) in the treatment of juvenile @entity2631 . METHODS: In this double-blind study, @entity1 with active juvenile @entity2631 were randomized (2:1) to receive oral @entity1500 (15 mg/m  , maximum 20 mg) or placebo once weekly, for 12 months or until treatment failure. Both groups received oral @entity229 (1 mg/kg/day, maximum 50 mg) for the first 3 months. @entity75 was evaluated clinically, with infrared thermography and using a computerized scoring system with skin score rate ( @entity54909 ) evaluation. Response to treatment was defined as the absence of new lesions, @entity54909 , and a decrease in lesion temperature of at least 10% compared to baseline. Treatment failure was defined as the occurrence of new lesions, @entity54909 , or increased lesion temperature. All analyses were done on the intent-to-treat population. RESULTS: Of the 85 @entity1 screened, 70 (ages 6-17 years) were randomized (46 to the @entity1500 group, 24 to the placebo group). The mean disease duration was 2.3 years. After an initial response in all @entity1 , disease relapsed in 15 @entity1500 -treated @entity1 (32.6%) and 17 placebo-treated @entity1 (70.8%) (P < 0.005). New lesions appeared in 3 @entity1500 -treated @entity1 (6.5%) versus 4 placebo-treated @entity1 (16.7%). The mean @entity54909 decreased from 1 to 0.79 in the @entity1500 group and increased from 1 to 1.1 in the placebo group, and the mean @entity75 temperature decreased by 44.4% in the @entity1500 group versus 12.1% in the placebo group. Twenty-six @entity1 in the @entity1500 group (56.5%) and 11 @entity1 in the placebo group (45.8%) developed mild side effects related to treatment. None of the side effects were severe enough to necessitate treatment discontinuation. CONCLUSION: Our findings indicate that @entity1500 is efficacious in the treatment of juvenile @entity2631 and is well tolerated.
