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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Pimecrolimus

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, AD, pimecrolimus, blood, absorption, systemic

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pimecrolimus cream 1%

Arm Description

Pimecrolimus

Outcomes

Primary Outcome Measures

Pimecrolimus blood concentration

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00925730

First Posted

June 17, 2009

Last Updated

November 16, 2016

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00925730

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pimecrolimus cream 1%

Arm Type

Experimental

Arm Description

Pimecrolimus

Intervention Type

Drug

Intervention Name(s)

Pimecrolimus

Primary Outcome Measure Information:

Title

Pimecrolimus blood concentration

Time Frame

Days 1, 9, 16

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Bonn

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt am Main

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21099191

Citation

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.

Results Reference

result

Learn more about this trial

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

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