Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00510003
• Collaborator: (none)
• Enrollment: 117
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. • 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Madrid		Spain

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Chair: Novartis, Novartis Pharma AG Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00510003
• Other Study ID Numbers: CASM981CES02
• First Posted: Aug 1, 2007
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Novartis Pharmaceuticals: Atopic dermatitis, children, pimecrolimus, eczema
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pimecrolimus

Study Results

No Results Posted as of Nov 18, 2016