CLINICAL TRIALS PROFILE FOR ELIDEL
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All Clinical Trials for Elidel
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00117377 ↗ | Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis | Completed | Novartis | Phase 4 | 2004-04-01 | The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied. |
| NCT00119158 ↗ | Combination Therapy for Atopic Dermatitis | Completed | Novartis Pharmaceuticals | Phase 4 | 2004-10-01 | Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids. |
| NCT00119158 ↗ | Combination Therapy for Atopic Dermatitis | Completed | Children's Hospital of Philadelphia | Phase 4 | 2004-10-01 | Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids. |
| NCT00120302 ↗ | Quality of Life Study in Adults With Facial Eczema | Completed | Novartis | Phase 4 | 2005-03-01 | This study is not being conducted in the US. The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study. Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit. |
| NCT00120523 ↗ | 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis | Completed | MEDA Pharma GmbH & Co. KG | Phase 3 | 2004-04-01 | The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS). |
| NCT00121316 ↗ | Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients | Completed | Novartis | Phase 4 | 2004-10-01 | This study is not being conducted in the United States. Patients who are intolerant of topical corticosteroids (TCS) have either experienced an adverse event resulting from the use of TCS, or require unacceptable levels of exposure to TCS in order to control their AD. This is of particular concern for patients with recurrent flares on delicate skin areas such as the head and neck. The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in patients who are intolerant of, or dependent on topical corticosteroids. |
| NCT00121381 ↗ | Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis | Completed | Novartis | Phase 4 | 2005-05-01 | 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 ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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