Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis

Novartis

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus Cream 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150059

CASM981CPH01

Details and patient eligibility

About

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)