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

Official Title: “Open Label Multicenter Study, 52 Weeks Duration, Using Pimecrolimus Cream 1% for the Long-term Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients Within a Usual Clinical Setting”

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

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus
  • Pimecrolimus cream 1 %

Primary Measures

• To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice, as assessed by: • Investigator Global Assessment • Facial Investigator Global Ass

Secondary Measures

• • To monitor the safety of pimecrolimus cream 1% in the long-term management as assessed by Adverse Events and Serious Adverse Events collection • To evaluate quality of life of both parent and patient assessed by questionnaire. • To determine ste

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis Pharma AG Basel, Switzerland  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509990

Study ID Number: CASM981CVE01

ClinicalTrials.gov Identifier: NCT00509990

Health Authority: Mexico: Secretaría de Salud, Estados Unidos Mexicanos