Official Title: “A Multicenter, 3-Week, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Pimecrolimus Cream 1% in Pediatric Patients With Mild to Moderate Atopic Dermatitis”

The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild to moderate atopic dermatitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus
  • Pimecrolimus cream 1 %

Primary Measures

• Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.

Secondary Measures

• • Reduction ≥ 50% in pruritus VAS with respect to basal score (responding patients) between groups and within groups (daily evaluation). • Change in sleep quality VAS in the pimecrolimus group with respect to the basal score (daily evaluation), and

Inclusion Criteria:

• Male or female.
• Age: between 2 - 12 years.
• Outpatients with diagnosis of atopic dermatitis
• Atopic dermatitis affecting ≥ 5% of Total Body Surface Area at Baseline Investigator's
• Global Assessment score of 2 (mild) or 3 (moderate).
• Baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe).
• Patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).

Exclusion Criteria:

• Patients being breast-fed by women receiving systemic or prohibited medication.
• Children with known hypersensitivity to study medication.
• Children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week.
• Children who received investigational drugs within 8 weeks prior to first application of study medication.
• Children who had concurrent skin disease or active bacterial, viral or fungal infection.
• Immunocompromised children (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or children with a history of malignant disease.
• Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 12 Years

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/NCT00510003

Study ID Number: CASM981CES02

ClinicalTrials.gov Identifier: NCT00510003

Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios