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Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00121381
First received: July 14, 2005
Last updated: January 10, 2008
Last verified: January 2008
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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:
Genetics Home Reference related topics:
atopic dermatitis
Drug Information available for:
Pimecrolimus
U.S. FDA Resources
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 (Child) |
| Sexes Eligible for Study: | All |
| 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
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
| 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 |
Keywords provided by Novartis:
|
Atopic dermatitis T-cell pimecrolimus children topical corticosteroids |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Eczema 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 Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 27, 2017