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

Last updated: April 10, 2020
Sponsor: Stiefel, a GSK Company
Overall Status: Completed

Phase

3

Condition

Allergy

Allergies & Asthma

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT00817063
117183
BAP01346
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • all types of chronic hand eczema, lasting for at least 6 months since initialdiagnosis

  • rated as severe by the physician

  • unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion

Exclusion Criteria:

  • patients whose disease is adequately controlled by standard non-medicated therapy,including potent topical steroids, skin moisturizers, and avoidance of allergens andirritants

  • patients with known allergens and irritants, who have not made a reasonable effort toavoid 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 twoeffective methods of contraception

Study Design

Total Participants: 599
Study Start date:
January 08, 2009
Estimated Completion Date:
April 26, 2012

Study 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.

Connect with a study center

  • University of Alabama, Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Radiant Research Inc.

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Dermatology Research of Arkansas

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Hull Dermatology

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Shahram Jacobs, MD, Inc.

    Encino, California 91436
    United States

    Site Not Available

  • University of California, San Diego Dermatology Clinical Trials Unit

    La Jolla, California 92037
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Laser and Dermatology Center

    Marina Del Rey, California 90292
    United States

    Site Not Available

  • Integrated Research Group

    Riverside, California 92506
    United States

    Site Not Available

  • University of California, Davis

    Sacramento, California 95816
    United States

    Site Not Available

  • Therapeutics Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

  • East Bay Psoriasis Treatment Center

    San Ramon, California 94583
    United States

    Site Not Available

  • Stanford University Dept of Dermatology

    Stanford, California 94305
    United States

    Site Not Available

  • Solano Clinical Research, Dow Pharmaceutical Sciences

    Vallejo, California 94589
    United States

    Site Not Available

  • Longmont Clinic, P.C.

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Western State Clinical Research Inc.

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • George Washington University - Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • George Washington University - Medical Faculty Associates

    Washington, D.C., District of Columbia 20037
    United States

    Site Not Available

  • Park Avenue Dermatology, PA

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Toccoa Clinic Medical Associates

    Toccoa, Georgia 30577
    United States

    Site Not Available

  • Saltzer Medical Group

    Nampa, Idaho 83687
    United States

    Site Not Available

  • Michael Bukhalo MD

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Dermassociates, Ltd

    Belleville, Illinois 62226
    United States

    Site Not Available

  • Schaumburg Dermatology

    Schaumburg, Illinois 60194
    United States

    Site Not Available

  • Dundee Dermatology

    West Dundee, Illinois 60118
    United States

    Site Not Available

  • Deaconess Clinic, Inc.

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Indiana University Dermatology

    Indianapolis, Indiana 37660
    United States

    Site Not Available

  • The Dermatology Center

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Dermatology Center of Indiana/Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Kansas City Dermatology, PA

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • American Dermatology Association

    Shawnee, Kansas 66216
    United States

    Site Not Available

  • American Dermatology Association

    Shawnee Mission, Kansas 66216
    United States

    Site Not Available

  • Kansas Medical Clinic

    Topeka, Kansas 66614
    United States

    Site Not Available

  • Derm Research, PLLC

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Dermatology Specialists

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tulane University Health Sciences, Dermatology Dept

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Hamzavi Dermatology Clinic

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Silverton Skin Institute

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48088
    United States

    Site Not Available

  • MAPS Applied Research Center

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Minnesota Clinical Studies Research Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Washington University Dermatology Research

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University Dermatology Research

    St.Louis, Missouri 63110
    United States

    Site Not Available

  • South Lincoln Dermatology

    Lincoln, Nebraska 68502
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • UMDNJ - Robert Wood Johnson School of Medicine, Dermatology

    Somerset, New Jersey 08873
    United States

    Site Not Available

  • Mount Sinai School of Medicine Clinical Dermatology

    New York, New York 10029
    United States

    Site Not Available

  • St.Luke's/Roosevelt Hospital Center

    New York, New York 10025
    United States

    Site Not Available

  • Helendale Dermatology and Medical Spa

    Rochester, New York 14609
    United States

    Site Not Available

  • Derm Research Center of New York Inc.

    Stony Brook, New York 11790
    United States

    Site Not Available

  • University of North Carolina, Dermatology Department

    Chapel Hill, North Carolina 918-843-9447
    United States

    Site Not Available

  • Azalea Research Center

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Wake Forrest University School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Bernstein Clinical Research Center

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Paddington Testing Co.Inc

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Dermatology Associates of Kingsport

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Tennessee Clinical Research Center

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Academy of Clinical Research

    Airlington, Texas 76011
    United States

    Site Not Available

  • Academy of Clinical Research

    Arlington, Texas 76011
    United States

    Site Not Available

  • Modern Research Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77030
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 77056
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • Fletcher Allen Health Care

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Virginia Clinical Research Inc.

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Dermatology and Laser Center NW

    Bellingham, Washington 98281
    United States

    Site Not Available

  • Premier Clinical Research

    Seattle, Washington 99204
    United States

    Site Not Available

  • Madison Skin & Research Inc.

    Madison, Wisconsin 53719
    United States

    Site Not Available

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