Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
HANDEL
Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy
3 other identifiers
interventional
599
1 country
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2009
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedStudy Start
First participant enrolled
January 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2012
CompletedResults Posted
Study results publicly available
November 9, 2017
CompletedApril 27, 2020
April 1, 2020
3.3 years
January 5, 2009
July 17, 2017
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24
The investigator assigned PGA grades according to a 5-point scale (clear \[not detectable\], almost clear \[less than 10% of affected hand surface\], mild disease \[less than 10% of affected hand surface\], moderate disease \[10% to 30% of affected hand surface\], severe disease \[\>30% of affected hand surface\]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.
Week 24 (end-of-treatment)
Secondary Outcomes (18)
Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment
Baseline (Week 0) and Week 24 (end-of-treatment)
Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment
Week 24 (end-of-treatment)
Percentage Change From Baseline in Extent of Disease at End-of-treatment
Baseline (Week 0) and Week 24 (end-of-treatment)
Response Duration for Responding Participants at the End-of-therapy
Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)
Time to Relapse for Responding Participants at the End-of-therapy
Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)
- +13 more secondary outcomes
Study Arms (2)
Alitretinoin
EXPERIMENTALPatients will receive alitretinoin 30mg capsule for up to 24 weeks
Placebo
EXPERIMENTALPatients will receive placebo 30mg capsule for up to 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- Basilea Pharmaceuticacollaborator
Study Sites (70)
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 D.C., 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
St 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, 918-843-9447, 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
Related Publications (4)
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.
PMID: 17868211BACKGROUNDRuzicka 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.
PMID: 15611422BACKGROUNDRuzicka 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.
PMID: 18294310BACKGROUNDFowler 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.
PMID: 25607554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
January 8, 2009
Primary Completion
April 26, 2012
Study Completion
April 26, 2012
Last Updated
April 27, 2020
Results First Posted
November 9, 2017
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD for this study will be made available via the Clinical Study Data Request site.
- Access Criteria
- IPD for this study will be made available via the Clinical Study Data Request site.
IPD for this study will be made available via the Clinical Study Data Request site.