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

Novartis

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130364

CASM981C2440

Details and patient eligibility

About

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.

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Pimecrolimus

Treatment:

Drug: Pimecrolimus

2

Placebo Comparator group

Description:

Pimecrolimus vehicle cream

Treatment:

Drug: Placebo