Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice

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

Details

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

Criteria

Inclusion Criteria:

• Age ≥ 3 months to 12 years old

• Clinical diagnosis of atopic dermatitis

• History of mild to moderate atopic dermatitis

• Investigator Global Assessment ≥ 1 (almost clear/clear of disease)

• Written informed consent

Exclusion Criteria:

• Investigator Global Assessment ≥ 4 (severe/very severe disease)

• Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella)

• Patients with atopic dermatitis, with active clinical infection on area of disease. All active infections must be treated prior to trial inclusion

• Patients in an Immunosuppressive state or with history of malignant disease

• Patients with clinical conditions other that Atopic Dermatitis that according to the investigator may interfere with the evaluation (i.e, Psoriasis, Netherton Syndrome)

• Other protocol-defined inclusion/exclusion criteria may apply