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

This study has been completed.
Sponsor:
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00817063
First received: January 5, 2009
Last updated: April 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Eczema
Drug: alitretinoin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Response as assessed by Physicans Global Assessment (PGA) [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients Global Assessment (PaGA) [ Time Frame: 24 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
  • Modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]
  • Extent of disease [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests [ Time Frame: continuosly during treatment ] [ Designated as safety issue: Yes ]
  • Psychiatric questionaires (BSI-53, GHQ-9) [ Time Frame: continously during treatment ] [ Designated as safety issue: Yes ]
  • Bone densitometry and bone x-rays [ Time Frame: 24 weeks (end-of treatment), follow-up 48 weeks post treatment ] [ Designated as safety issue: Yes ]
  • Ophthalmologic evaluation [ Time Frame: 24 weeks (end of treatment) ] [ Designated as safety issue: Yes ]
  • Audiologic evaluation [ Time Frame: 24 weeks (end-of-treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: January 2009
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alitretinoin
Patients will receive alitretinoin 30mg capsule for up to 24 weeks
Drug: alitretinoin
Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks
Experimental: Placebo
Patients will receive placebo 30mg capsule for up to 24 weeks
Drug: Placebo
Patients receive matching placebo for up to 24 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817063

  Hide Study Locations
Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Radiant Research Inc.
Tucson, Arizona, United States, 85710
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
Hull Dermatology
Rogers, Arkansas, United States, 72758
United States, California
Shahram Jacobs, MD, Inc.
Encino, California, United States, 91436
University of California, San Diego Dermatology Clinical Trials Unit
La Jolla, California, United States, 92037
Dermatology Research Associates
Los Angeles, California, United States, 90045
Laser and Dermatology Center
Marina del Rey, California, United States, 90292
Integrated Research Group
Riverside, California, United States, 92506
University of California, Davis
Sacramento, California, United States, 95816
Therapeutics Clinical Research
San Diego, California, United States, 92123
East Bay Psoriasis Treatment Center
San Ramon, California, United States, 94583
Stanford University Dept of Dermatology
Stanford, California, United States, 94305
Solano Clinical Research, Dow Pharmaceutical Sciences
Vallejo, California, United States, 94589
United States, Colorado
Longmont Clinic, P.C.
Longmont, Colorado, United States, 80501
Western State Clinical Research Inc.
Wheat Ridge, Colorado, United States, 80033
United States, District of Columbia
George Washington University - Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Toccoa Clinic Medical Associates
Toccoa, Georgia, United States, 30577
United States, Idaho
Saltzer Medical Group
Nampa, Idaho, United States, 83687
United States, Illinois
Michael Bukhalo MD
Arlington Heights, Illinois, United States, 60005
Dermassociates, Ltd
Belleville, Illinois, United States, 62226
Schaumburg Dermatology
Schaumburg, Illinois, United States, 60194
Dundee Dermatology
West Dundee, Illinois, United States, 60118
United States, Indiana
Deaconess Clinic, Inc.
Evansville, Indiana, United States, 47713
Indiana University Dermatology
Indianapolis, Indiana, United States, 37660
The Dermatology Center
New Albany, Indiana, United States, 47150
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Kansas
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
American Dermatology Association
Shawnee, Kansas, United States, 66216
Kansas Medical Clinic
Topeka, Kansas, United States, 66614
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Derm Research, PLLC
Louisville, Kentucky, United States, 40217
United States, Louisiana
Tulane University Health Sciences, Dermatology Dept
New Orleans, Louisiana, United States, 70112
United States, Michigan
Hamzavi Dermatology Clinic
Fort Gratiot, Michigan, United States, 48059
Silverton Skin Institute
Grand Blanc, Michigan, United States, 48439
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Minnesota
MAPS Applied Research Center
Edina, Minnesota, United States, 55435
Minnesota Clinical Studies Research Center
Fridley, Minnesota, United States, 55432
United States, Missouri
Washington University Dermatology Research
St.Louis, Missouri, United States, 63110
United States, Nebraska
South Lincoln Dermatology
Lincoln, Nebraska, United States, 68502
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
UMDNJ - Robert Wood Johnson School of Medicine, Dermatology
Somerset, New Jersey, United States, 08873
United States, New York
St.Luke's/Roosevelt Hospital Center
New York, New York, United States, 10025
Mount Sinai School of Medicine Clinical Dermatology
New York, New York, United States, 10029
Helendale Dermatology and Medical Spa
Rochester, New York, United States, 14609
Derm Research Center of New York Inc.
Stony Brook, New York, United States, 11790
United States, North Carolina
University of North Carolina, Dermatology Department
Chapel Hill, North Carolina, United States, 918-843-9447
Azalea Research Center
Wilmington, North Carolina, United States, 28403
Wake Forrest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Bernstein Clinical Research Center
Cincinnati, Ohio, United States, 45242
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Paddington Testing Co.Inc
Philadelphia, Pennsylvania, United States, 19103
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Dermatology Associates of Kingsport
Kingsport, Tennessee, United States, 37660
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Academy of Clinical Research
Airlington, Texas, United States, 76011
Modern Research Associates
Dallas, Texas, United States, 75231
Center for Clinical Studies
Houston, Texas, United States, 77030
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 77056
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Clinical Research Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology and Laser Center NW
Bellingham, Washington, United States, 98281
Premier Clinical Research
Seattle, Washington, United States, 99204
United States, Wisconsin
Madison Skin & Research Inc.
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Stiefel, a GSK Company
Basilea Pharmaceutica
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00817063     History of Changes
Other Study ID Numbers: 117183, BAP01346
Study First Received: January 5, 2009
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
retinoid treatment
fingertip dermatitis
hyperkeratotic hand eczema
vesicular hand eczema
pompholyx

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Alitretinoin
Tretinoin
Antineoplastic Agents
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014