Status:
COMPLETED
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
Lead Sponsor:
Novartis
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
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) ove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00925730
Start Date
March 1 2004
Last Update
November 18 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Bonn, Germany
2
Novartis Investigative Site
Frankfurt am Main, Germany