NCT00121381

Brief Summary

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

July 14, 2005

Last Update Submit

January 10, 2008

Conditions

Dermatitis, Atopic

Keywords

Atopic dermatitisT-cellpimecrolimuschildrentopical corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Secondary Outcomes (5)

  • Incidence of all other adverse events

  • Time to relapse of atopic dermatitis

  • Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)

  • Efficacy measured by IGA (treatment success and improvement)

  • Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus 1 % cream plus topical corticosteroid (TCS)

Drug: Pimecrolimus plus topical corticosteroid (TCS)

2

PLACEBO COMPARATOR

Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Interventions

Pimecrolimus plus topical corticosteroid (TCS)DRUG

Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily

Also known as: Elidel
1
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)DRUG

twice daily administration

2

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Severe atopic dermatitis
  • % of total body surface area (TBSA) affected

You may not qualify if:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Pediatric Care Medical Group, Inc.

Huntington Beach, California, 92647, United States

Location

Children's Hospital -San Diego

San Diego, California, 92123, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Dermatology Associates and Research

Coral Gables, Florida, 33134, United States

Location

Medical College of Georgia - Clinical Investigative Services

Augusta, Georgia, 30912, United States

Location

Dartmouth Hitchcock Medical Center Section of Dermatology

Lebanon, New Hampshire, 03756, United States

Location

Wake Forest University School of Medicine Dept. of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Calcagno Research and Development

Gresham, Oregon, 97030, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

520 Trinity Creek Cove

Cordova, Tennessee, 38018, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

A.S.T.H.M.A., Inc

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimusAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2005

First Posted

July 21, 2005

Study Start

May 1, 2005

Study Completion

January 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(13)