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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR PIMECROLIMUS

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All Clinical Trials for Pimecrolimus

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 >Phase >Start Date >Summary

Clinical Trial Conditions for Pimecrolimus

Condition Name

Condition Name for Pimecrolimus
Intervention Trials
Atopic Dermatitis 26
Dermatitis, Atopic 5
Oral Lichen Planus 5
Seborrheic Dermatitis 2
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Condition MeSH

Condition MeSH for Pimecrolimus
Intervention Trials
Dermatitis 37
Eczema 33
Dermatitis, Atopic 33
Lichen Planus 7
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Clinical Trial Locations for Pimecrolimus

Trials by Country

Trials by Country for Pimecrolimus
Location Trials
United States 140
Germany 12
Switzerland 3
Iran, Islamic Republic of 2
Canada 2
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Trials by US State

Trials by US State for Pimecrolimus
Location Trials
California 8
Florida 7
Texas 7
Virginia 7
Pennsylvania 7
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Clinical Trial Progress for Pimecrolimus

Clinical Trial Phase

Clinical Trial Phase for Pimecrolimus
Clinical Trial Phase Trials
Phase 4 23
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Pimecrolimus
Clinical Trial Phase Trials
Completed 41
Recruiting 4
Terminated 3
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Clinical Trial Sponsors for Pimecrolimus

Sponsor Name

Sponsor Name for Pimecrolimus
Sponsor Trials
Novartis 22
Novartis Pharmaceuticals 7
Astellas Pharma Inc 3
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Sponsor Type

Sponsor Type for Pimecrolimus
Sponsor Trials
Industry 38
Other 37
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