Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Novartis

Status and phase: Completed; Phase 4

Conditions: Dermatitis, Atopic

Treatments: Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS); Drug: Pimecrolimus plus topical corticosteroid (TCS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00121381

CASM981C2439

Details and patient eligibility

About

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe atopic dermatitis
• 5% of total body surface area (TBSA) affected

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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400 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Pimecrolimus 1 % cream plus topical corticosteroid (TCS)

Treatment:

Drug: Pimecrolimus plus topical corticosteroid (TCS)

2

Placebo Comparator group

Description:

Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Treatment:

Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)