Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
NCT ID: NCT00925730
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pimecrolimus cream 1%
Pimecrolimus
Pimecrolimus
Interventions
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Pimecrolimus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Frankfurt am Main, , Germany
Countries
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References
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Thaci D, Kaufmann R, Bieber T, Hanfland J, Hauffe S, Koehne-Voss S, Waldmeier F. Percutaneous absorption of pimecrolimus is not increased in patients with moderate to severe atopic dermatitis when pimecrolimus cream 1% is applied under occlusion. Dermatology. 2010;221(4):342-51. doi: 10.1159/000320125. Epub 2010 Nov 22.
Other Identifiers
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CASM981C2313
Identifier Type: -
Identifier Source: org_study_id