Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Atopic Dermatitis

Primary Objective:

To evaluate safety (4 weeks)

Secondary Objectives:

• To evaluate the long-term safety (12 weeks)
• To evaluate the efficacy
• To characterize the pharmacokinetic profile

The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Inclusion criteria:

• Aged 6 months through 11 years
• Patients with atopic dermatitis

Exclusion criteria:

• Main itching scores are 4 or less than 2 on last three consecutive days before registration.
• Patients who have itching only on face, head, or diaper area.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.