An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Openlabel Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Childre

Phase 1

• Conditions: Atopic Dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-001765-25-Outside-EU/EEA
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1091

Inclusion Criteria

• Diagnosis of atopic dermatitis
• Family history of atopy
• 3 to 18 months of age at baseline
At least mild atopic dermatitis at baseline (investigator global
assessment [IGA] greater or equal to 2)
• Clinical evidence of atopic dermatitis for no longer than 3 months
Are the trial subjects under 18? yes
Number of subjects for this age range: 1091
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

• Diagnosis of or substantial clinical evidence for food or other allergies
at baseline

Study & Design

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