Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pimecrolimus; Tacrolimus

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