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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00925730

Enrollment

Registered

2009-06-22

Start date

2004-03-31

Completion date

Unknown

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, AD, pimecrolimus, blood, absorption, systemic

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.

Interventions

DRUGPimecrolimus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Pimecrolimus blood concentration	Days 1, 9, 16

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026