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 Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
Overview
- Phase
- Phase 4
- Intervention
- Pimecrolimus
- Conditions
- Atopic Dermatitis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1091
- Locations
- 36
- Primary Endpoint
- Atopic Dermatitis (AD) Disease Control Over 36 Months
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
Brief Summary
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.
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
Exclusion Criteria
- •Diagnosis of or substantial clinical evidence for food or other allergies at baseline
- •Other protocol related criteria may apply
Arms & Interventions
1
Pimecrolimus
Intervention: Pimecrolimus
2
Corticosteroid
Intervention: Corticosteroid
Outcomes
Primary Outcomes
Atopic Dermatitis (AD) Disease Control Over 36 Months
Time Frame: 36 months
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Time Frame: 6 years
Note: The results for this efficacy variable are not reported due to early termination of the study.
Secondary Outcomes
- Long Term Safety in Infants and Young Children(6 years)
- Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies(6 years (36 month Double-Blind Phase))
- Corticosteroid and Pimecrolimus Drug Use(48 months)
- Atopic Dermatitis (AD) Remission Time(36 month Double-Blind Phase)
- Patient/Caregiver Quality of Life(From Baseline to Visit 5 , 6, 8, 10, 12, and 14)