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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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 Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis Pharma AG Basel, Switzerland  

Information obtained from ClinicalTrials.gov on November 20, 2008

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