Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT00121381 |
Recruitment Status :
Completed
First Posted : July 21, 2005
Last Update Posted : January 15, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dermatitis, Atopic | Drug: Pimecrolimus plus topical corticosteroid (TCS) Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis |
Study Start Date : | May 2005 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
---|---|
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 |
- Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
- 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

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121381
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 |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | External Affairs, Novartis |
ClinicalTrials.gov Identifier: | NCT00121381 |
Other Study ID Numbers: |
CASM981C2439 |
First Posted: | July 21, 2005 Key Record Dates |
Last Update Posted: | January 15, 2008 |
Last Verified: | January 2008 |
Atopic dermatitis T-cell pimecrolimus children topical corticosteroids |
Dermatitis, Atopic Dermatitis 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 |