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

Novartis Pharmaceuticals1 site in 1 country117 target enrollmentDecember 2004

ConditionsAtopic Dermatitis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Novartis Pharmaceuticals
Enrollment: 117
Locations: 1
Primary Endpoint: Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

January 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

• 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