Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00121381
First received: July 14, 2005
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: Pimecrolimus plus topical corticosteroid (TCS)
Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: May 2005
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: 1
Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
Drug: Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
Other Name: Elidel
Placebo Comparator: 2
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe atopic dermatitis
  • 5% of total body surface area (TBSA) affected

Exclusion Criteria:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121381

Locations
United States, California
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
Children's Hospital -San Diego
San Diego, California, United States, 92123
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
Dermatology Associates and Research
Coral Gables, Florida, United States, 33134
United States, Georgia
Medical College of Georgia - Clinical Investigative Services
Augusta, Georgia, United States, 30912
United States, New Hampshire
Dartmouth Hitchcock Medical Center Section of Dermatology
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Wake Forest University School of Medicine Dept. of Dermatology
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Calcagno Research and Development
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
520 Trinity Creek Cove
Cordova, Tennessee, United States, 38018
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
A.S.T.H.M.A., Inc
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00121381     History of Changes
Other Study ID Numbers: CASM981C2439
Study First Received: July 14, 2005
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
South Africa: Medicines Control Council

Keywords provided by Novartis:
Atopic dermatitis
T-cell
pimecrolimus
children
topical corticosteroids

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014