Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00130364
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
• Study Start Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pimecrolimus	Drug: Pimecrolimus; Pimecrolimus 1 % cream; Other Names: Elidel
Placebo Comparator: 2 Pimecrolimus vehicle cream	Drug: Placebo; Pimecrolimus vehicle cream (placebo)

Outcome Measures

Primary Outcome Measures

1. The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) []

Secondary Outcome Measures

1. Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score []

2. The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score []

3. The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild) []

4. Time to clearance of facial IGA (score of 0 or 1) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 11 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Mild to moderate facial atopic dermatitis

• Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria:

• Concurrent skin diseases (infections)

• Immunocompromised

• Recently received phototherapy or systemic therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	This study is not being conducted in the United States	Novartis Pharmaceuticals	New Jersey	United States

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00130364
• Other Study ID Numbers: CASM981C2440
• First Posted: Aug 15, 2005
• Last Update Posted: Jan 15, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Atopic dermatitis; T-cell; pimecrolimus; children; facial; Facial atopic dermatitis
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pimecrolimus

Study Results

No Results Posted as of Jan 15, 2008