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

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 19.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-000251-74-Outside-EU/EEA
• Lead Sponsor: Sanofi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified