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

Atopic Dermatitis Clinical Trial

Official title:

Non-comparative Open-label Study to Investigate the Efficacy, Safety and Systemic Exposure of Pimecrolimus in Adult and Pediatric Patients With Moderate to Severe Atopic Dermatitis Treated Topically for 8.5 Days With Pimecrolimus Cream 1% Under Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925730
• Other study ID #: CASM981C2313
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2009
• Last updated: November 16, 2016
• Start date: March 2004

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Thaçi 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. Dermatol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pimecrolimus blood concentration		Days 1, 9, 16	No
Secondary	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	No

External Links

•   Results for CASM981C2313 from the Novartis Clinical Trials Website