Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

Novartis

Status and phase: Terminated; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus; Drug: Corticosteroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00124709

CASM981CUS09

Details and patient eligibility

About

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Enrollment: 1,091 patients

Sex: All

Ages: 3 to 18 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of atopic dermatitis
• Family history of atopy
• 3 to 18 months of age at baseline
• At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)
• Clinical evidence of atopic dermatitis for no longer than 3 months

Exclusion criteria

• Diagnosis of or substantial clinical evidence for food or other allergies at baseline

Other protocol related criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,091 participants in 2 patient groups

1

Experimental group

Description:

Pimecrolimus

Treatment:

Drug: Pimecrolimus

2

Active Comparator group

Description:

Corticosteroid

Treatment:

Drug: Corticosteroid