Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion

Novartis

Status and phase

Completed

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Pimecrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00925730

CASM981C2313

Details and patient eligibility

About

This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.

Enrollment

20 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 2 - 18 years of age
Patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the Investigator's Global Assessment. AD to involve at least 30% of their body surface area as determined by the rule of nine or the Lund and Browder chart.

Exclusion criteria

Erythrodermic patients with Netherton's syndrome
Patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication
Patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive HIV (ELISA and Western blot), Hepatitis B surface antigen (HBsAg) or Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply