Psoriasis Clinical Trial

Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema

Summary

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

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Full Description

Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
rated as severe by the physician
unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
patients with psoriasis lesions
active fungal, bacterial or viral infections of the hands
female patients who are pregnant or breastfeeding
female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

599

Study ID:

NCT00817063

Recruitment Status:

Completed

Sponsor:

Stiefel, a GSK Company

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There are 69 Locations for this study

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University of Alabama, Birmingham
Birmingham Alabama, 35233, United States
Radiant Research Inc.
Tucson Arizona, 85710, United States
Johnson Dermatology
Fort Smith Arkansas, 72916, United States
Dermatology Research of Arkansas
Little Rock Arkansas, 72205, United States
Hull Dermatology
Rogers Arkansas, 72758, United States
Shahram Jacobs, MD, Inc.
Encino California, 91436, United States
University of California, San Diego Dermatology Clinical Trials Unit
La Jolla California, 92037, United States
Dermatology Research Associates
Los Angeles California, 90045, United States
Laser and Dermatology Center
Marina Del Rey California, 90292, United States
Integrated Research Group
Riverside California, 92506, United States
University of California, Davis
Sacramento California, 95816, United States
Therapeutics Clinical Research
San Diego California, 92123, United States
East Bay Psoriasis Treatment Center
San Ramon California, 94583, United States
Stanford University Dept of Dermatology
Stanford California, 94305, United States
Solano Clinical Research, Dow Pharmaceutical Sciences
Vallejo California, 94589, United States
Longmont Clinic, P.C.
Longmont Colorado, 80501, United States
Western State Clinical Research Inc.
Wheat Ridge Colorado, 80033, United States
George Washington University - Medical Faculty Associates
Washington District of Columbia, 20037, United States
Park Avenue Dermatology, PA
Orange Park Florida, 32073, United States
Palm Beach Research Center
West Palm Beach Florida, 33409, United States
Toccoa Clinic Medical Associates
Toccoa Georgia, 30577, United States
Saltzer Medical Group
Nampa Idaho, 83687, United States
Michael Bukhalo MD
Arlington Heights Illinois, 60005, United States
Dermassociates, Ltd
Belleville Illinois, 62226, United States
Schaumburg Dermatology
Schaumburg Illinois, 60194, United States
Dundee Dermatology
West Dundee Illinois, 60118, United States
Deaconess Clinic, Inc.
Evansville Indiana, 47713, United States
Indiana University Dermatology
Indianapolis Indiana, 37660, United States
The Dermatology Center
New Albany Indiana, 47150, United States
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield Indiana, 46168, United States
Kansas City Dermatology, PA
Overland Park Kansas, 66215, United States
American Dermatology Association
Shawnee Mission Kansas, 66216, United States
Kansas Medical Clinic
Topeka Kansas, 66614, United States
Dermatology Specialists
Louisville Kentucky, 40202, United States
Derm Research, PLLC
Louisville Kentucky, 40217, United States
Tulane University Health Sciences, Dermatology Dept
New Orleans Louisiana, 70112, United States
Hamzavi Dermatology Clinic
Fort Gratiot Michigan, 48059, United States
Silverton Skin Institute
Grand Blanc Michigan, 48439, United States
Grekin Skin Institute
Warren Michigan, 48088, United States
MAPS Applied Research Center
Edina Minnesota, 55435, United States
Minnesota Clinical Studies Research Center
Fridley Minnesota, 55432, United States
Washington University Dermatology Research
Saint Louis Missouri, 63110, United States
South Lincoln Dermatology
Lincoln Nebraska, 68502, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
UMDNJ - Robert Wood Johnson School of Medicine, Dermatology
Somerset New Jersey, 08873, United States
St.Luke's/Roosevelt Hospital Center
New York New York, 10025, United States
Mount Sinai School of Medicine Clinical Dermatology
New York New York, 10029, United States
Helendale Dermatology and Medical Spa
Rochester New York, 14609, United States
Derm Research Center of New York Inc.
Stony Brook New York, 11790, United States
University of North Carolina, Dermatology Department
Chapel Hill North Carolina, 918-8, United States
Azalea Research Center
Wilmington North Carolina, 28403, United States
Wake Forrest University School of Medicine
Winston-Salem North Carolina, 27157, United States
Bernstein Clinical Research Center
Cincinnati Ohio, 45242, United States
Oregon Dermatology and Research Center
Portland Oregon, 97210, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Paddington Testing Co.Inc
Philadelphia Pennsylvania, 19103, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Dermatology Associates of Kingsport
Kingsport Tennessee, 37660, United States
Tennessee Clinical Research Center
Nashville Tennessee, 37215, United States
Academy of Clinical Research
Arlington Texas, 76011, United States
Modern Research Associates
Dallas Texas, 75231, United States
Center for Clinical Studies
Houston Texas, 77030, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 77056, United States
Center for Clinical Studies
Webster Texas, 77598, United States
Fletcher Allen Health Care
Burlington Vermont, 05401, United States
Virginia Clinical Research Inc.
Norfolk Virginia, 23507, United States
Dermatology and Laser Center NW
Bellingham Washington, 98281, United States
Premier Clinical Research
Seattle Washington, 99204, United States
Madison Skin & Research Inc.
Madison Wisconsin, 53719, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

599

Study ID:

NCT00817063

Recruitment Status:

Completed

Sponsor:


Stiefel, a GSK Company

How clear is this clinincal trial information?

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