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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR ELIDEL

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Clinical Trials for Elidel

Trial ID Title Status Sponsor Phase Summary
NCT00117377 Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis Completed Novartis Phase 4 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 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 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Elidel

Condition Name

Condition Name for Elidel
Intervention Trials
Atopic Dermatitis 22
Dermatitis, Atopic 4
Lupus Erythematosus, Discoid 1
Seborrheic Dermatitis 1
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Condition MeSH

Condition MeSH for Elidel
Intervention Trials
Dermatitis 29
Eczema 27
Dermatitis, Atopic 27
Lupus Erythematosus, Systemic 2
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Clinical Trial Locations for Elidel

Trials by Country

Trials by Country for Elidel
Location Trials
United States 147
Germany 10
Canada 3
Japan 2
Iran, Islamic Republic of 1
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Trials by US State

Trials by US State for Elidel
Location Trials
California 10
Florida 8
Texas 8
Virginia 8
North Carolina 8
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Clinical Trial Progress for Elidel

Clinical Trial Phase

Clinical Trial Phase for Elidel
Clinical Trial Phase Trials
Phase 4 15
Phase 3 9
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Elidel
Clinical Trial Phase Trials
Completed 30
Recruiting 3
Unknown status 2
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Clinical Trial Sponsors for Elidel

Sponsor Name

Sponsor Name for Elidel
Sponsor Trials
Novartis 13
Novartis Pharmaceuticals 4
Astellas Pharma Inc 3
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Sponsor Type

Sponsor Type for Elidel
Sponsor Trials
Industry 31
Other 15
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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Colorcon
Boehringer Ingelheim
Julphar
Federal Trade Commission
US Department of Justice
UBS
Argus Health
Cipla

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