Expired Study
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Novartis Pharmaceuticals, New Jersey


Purpose:

This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.


Criteria:

Inclusion Criteria: - Mild to moderate facial atopic dermatitis - Patients intolerant of, or dependent on, topical corticosteroids Exclusion Criteria: - Concurrent skin diseases (infections) - Immunocompromised - Recently received phototherapy or systemic therapy


Study is Available At:


Original ID:

CASM981C2440


NCT ID:

NCT00130364


Secondary ID:


Study Acronym:


Brief Title:

Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis


Official Title:

Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

2 Years


Maximum Age:

11 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

  • Germany: Federal Institute for Drugs and Medical Devices
  • South Korea: Korea Food and Drug Administration (KFDA)
  • Slovakia: State Institute for Drug Control


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Chair
Novartis Pharmaceuticals

Study Dates

Start Date:August 2005
Completion Date:August 2006
Completion Type:Actual
Verification Date:January 2008
Last Changed Date:January 10, 2008
First Received Date:August 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to clearance of facial IGA (score of 0 or 1)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pimecrolimus
Description:Pimecrolimus 1 % cream
Arm Name:1
Other Name:Elidel
Intervention Type:Drug
Name:Placebo
Description:Pimecrolimus vehicle cream (placebo)
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Pimecrolimus
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Pimecrolimus vehicle cream

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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