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

NCT ID: NCT00817063

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 599 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-08
• Study Completion Date: 2012-04-26

Brief 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.

Detailed 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.

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alitretinoin

Patients will receive alitretinoin 30mg capsule for up to 24 weeks

Group Type: EXPERIMENTAL

alitretinoin

Intervention Type: DRUG

Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks

Placebo

Patients will receive placebo 30mg capsule for up to 24 weeks

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Patients receive matching placebo for up to 24 weeks

Interventions

alitretinoin

Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks

Intervention Type: DRUG

Placebo

Patients receive matching placebo for up to 24 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

University of Alabama, Birmingham

Birmingham, Alabama, United States

Radiant Research Inc.

Tucson, Arizona, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

Dermatology Research of Arkansas

Little Rock, Arkansas, United States

Hull Dermatology

Rogers, Arkansas, United States

Shahram Jacobs, MD, Inc.

Encino, California, United States

University of California, San Diego Dermatology Clinical Trials Unit

La Jolla, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Laser and Dermatology Center

Marina del Rey, California, United States

Integrated Research Group

Riverside, California, United States

University of California, Davis

Sacramento, California, United States

Therapeutics Clinical Research

San Diego, California, United States

East Bay Psoriasis Treatment Center

San Ramon, California, United States

Stanford University Dept of Dermatology

Stanford, California, United States

Solano Clinical Research, Dow Pharmaceutical Sciences

Vallejo, California, United States

Longmont Clinic, P.C.

Longmont, Colorado, United States

Western State Clinical Research Inc.

Wheat Ridge, Colorado, United States

George Washington University - Medical Faculty Associates

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

Park Avenue Dermatology, PA

Orange Park, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Toccoa Clinic Medical Associates

Toccoa, Georgia, United States

Saltzer Medical Group

Nampa, Idaho, United States

Michael Bukhalo MD

Arlington Heights, Illinois, United States

Dermassociates, Ltd

Belleville, Illinois, United States

Schaumburg Dermatology

Schaumburg, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Deaconess Clinic, Inc.

Evansville, Indiana, United States

Indiana University Dermatology

Indianapolis, Indiana, United States

The Dermatology Center

New Albany, Indiana, United States

Dermatology Center of Indiana/Indiana Clinical Trials Center

Plainfield, Indiana, United States

Kansas City Dermatology, PA

Overland Park, Kansas, United States

American Dermatology Association

Shawnee Mission, Kansas, United States

Kansas Medical Clinic

Topeka, Kansas, United States

Dermatology Specialists

Louisville, Kentucky, United States

Derm Research, PLLC

Louisville, Kentucky, United States

Tulane University Health Sciences, Dermatology Dept

New Orleans, Louisiana, United States

Hamzavi Dermatology Clinic

Fort Gratiot, Michigan, United States

Silverton Skin Institute

Grand Blanc, Michigan, United States

Grekin Skin Institute

Warren, Michigan, United States

MAPS Applied Research Center

Edina, Minnesota, United States

Minnesota Clinical Studies Research Center

Fridley, Minnesota, United States

Washington University Dermatology Research

St Louis, Missouri, United States

South Lincoln Dermatology

Lincoln, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

UMDNJ - Robert Wood Johnson School of Medicine, Dermatology

Somerset, New Jersey, United States

St.Luke's/Roosevelt Hospital Center

New York, New York, United States

Mount Sinai School of Medicine Clinical Dermatology

New York, New York, United States

Helendale Dermatology and Medical Spa

Rochester, New York, United States

Derm Research Center of New York Inc.

Stony Brook, New York, United States

University of North Carolina, Dermatology Department

Chapel Hill, North Carolina, United States

Azalea Research Center

Wilmington, North Carolina, United States

Wake Forrest University School of Medicine

Winston-Salem, North Carolina, United States

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Paddington Testing Co.Inc

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Dermatology Associates of Kingsport

Kingsport, Tennessee, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Academy of Clinical Research

Arlington, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Virginia Clinical Research Inc.

Norfolk, Virginia, United States

Dermatology and Laser Center NW

Bellingham, Washington, United States

Premier Clinical Research

Seattle, Washington, United States

Madison Skin & Research Inc.

Madison, Wisconsin, United States

Countries

United States

References

Diepgen TL, Agner T, Aberer W, Berth-Jones J, Cambazard F, Elsner P, McFadden J, Coenraads PJ. Management of chronic hand eczema. Contact Dermatitis. 2007 Oct;57(4):203-10. doi: 10.1111/j.1600-0536.2007.01179.x.

Reference Type: BACKGROUND

PMID: 17868211 (View on PubMed)

Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.

Reference Type: BACKGROUND

PMID: 15611422 (View on PubMed)

Ruzicka T, Lynde CW, Jemec GB, Diepgen T, Berth-Jones J, Coenraads PJ, Kaszuba A, Bissonnette R, Varjonen E, Hollo P, Cambazard F, Lahfa M, Elsner P, Nyberg F, Svensson A, Brown TC, Harsch M, Maares J. Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial. Br J Dermatol. 2008 Apr;158(4):808-17. doi: 10.1111/j.1365-2133.2008.08487.x. Epub 2008 Feb 21.

Reference Type: BACKGROUND

PMID: 18294310 (View on PubMed)

Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.

Reference Type: DERIVED

PMID: 25607554 (View on PubMed)

Other Identifiers

BAP01346

Identifier Type: OTHER

Identifier Source: secondary_id

NCT00817063

Identifier Type: REGISTRY

Identifier Source: secondary_id

117183

Identifier Type: -

Identifier Source: org_study_id