Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
- Registration Number
- NCT00925730
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pimecrolimus cream 1% Pimecrolimus Pimecrolimus
- Primary Outcome Measures
Name Time Method Pimecrolimus blood concentration Days 1, 9, 16
- Secondary Outcome Measures
Name Time Method Efficacy as assessed by the Eczema Area and Severity Index and the Investigators Global Assessment of disease severity. Efficacy outcomes were of an exploratory nature in this study. Days 1, 9, 16
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Frankfurt am Main, Germany