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Completed

NCT Number: NCT00925730

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Bonn, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus

Drug

Primary outcomes

  1. Pimecrolimus blood concentration

    Time frame: Days 1, 9, 16

Secondary outcomes

  1. 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.

    Time frame: Days 1, 9, 16

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
First posted
Jun 22, 2009
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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