EUCTR2017-001765-25-Outside-EU/EEA
Active, not recruiting
Phase 1
An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Doubleblind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
DrugsElidel
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis
- Enrollment
- 1091
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Diagnosis of or substantial clinical evidence for food or other allergies
- •at baseline
Outcomes
Primary Outcomes
Not specified
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