Conditions: Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 587
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Detailed description:
Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant. Pimecrolimus inhibits T cell activation by blocking the transcription of early cytokines. Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. This study is being conducted to evaluate the clinical bioequivalence of sponsor's formulation of Pimecrolimus Cream, 1%, the Test product, and Elidel Cream, 1%, the Reference product. A vehicle control arm is included to demonstrate that the Test and Reference products are active and to establish that the study is sufficiently sensitive to detect differences between products.

Arms:
arm 1: Pimecrolimus Cream, 1% (Actavis) arm 2: Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC) arm 3: Cream vehicle of the test product (Actavis)

Interventions: intervention 1: Pimecrolimus Cream 1% (Valeant) intervention 2: Vehicle cream intervention 3: Pimecrolimus Cream, 1%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: