CLINICAL TRIALS PROFILE FOR PIMECROLIMUS

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.

Clinical Trial Conditions for PIMECROLIMUS

Condition Name

Condition Name for PIMECROLIMUS
Intervention	Trials
Atopic Dermatitis	27
Dermatitis, Atopic	5
Oral Lichen Planus	5
Seborrheic Dermatitis	2

Condition MeSH

Condition MeSH for PIMECROLIMUS
Intervention	Trials
Dermatitis	39
Dermatitis, Atopic	35
Eczema	34
Lichen Planus	7

Clinical Trial Locations for PIMECROLIMUS

Trials by Country

Trials by Country for PIMECROLIMUS
Location	Trials
United States	156
Germany	12
Switzerland	3
Canada	2
Japan	2

Trials by US State

Trials by US State for PIMECROLIMUS
Location	Trials
Texas	8
Virginia	8
Pennsylvania	8
North Carolina	8
Florida	8

Clinical Trial Progress for PIMECROLIMUS

Clinical Trial Phase

Clinical Trial Phase for PIMECROLIMUS
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	11
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for PIMECROLIMUS
Clinical Trial Phase	Trials
Completed	45
Terminated	5
Unknown status	4

Clinical Trial Sponsors for PIMECROLIMUS

Sponsor Name

Sponsor Name for PIMECROLIMUS
Sponsor	Trials
Novartis	22
Novartis Pharmaceuticals	7
Technische Universität Dresden	3

Sponsor Type

Sponsor Type for PIMECROLIMUS
Sponsor	Trials
Industry	41
Other	41