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Trial #NCT00817063
Eczema Clinical Trials

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


Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy
Study ID: 117183; Secondary ID: BAP01346; Source: GlaxoSmithKline
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country United States
Study type Interventional
Enrollment 600
Start date January 2009
Completion date August 2012
Phase Phase 3
Sponsor GlaxoSmithKline
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.
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:
Gender: Both
Age: 18 Years - 75 Years
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
Outcome:
Primary outcome
  • Response as assessed by Physicans Global Assessment (PGA)
    Time frame: 24 weeks (end-of treatment)
Secondary outcome
  • Adverse events, laboratory tests
    Time frame: continuosly during treatment
  • Audiologic evaluation
    Time frame: 24 weeks (end-of-treatment)
  • Bone densitometry and bone x-rays
    Time frame: 24 weeks (end-of treatment), follow-up 48 weeks post treatment
  • Extent of disease
    Time frame: 24 weeks (end-of treatment)
  • Modified Total Lesion Symptom Score (mTLSS)
    Time frame: 24 weeks (end-of treatment)
  • Ophthalmologic evaluation
    Time frame: 24 weeks (end of treatment)
  • Patients Global Assessment (PaGA)
    Time frame: 24 weeks (end-of-treatment)
  • Psychiatric questionaires (BSI-53, GHQ-9)
    Time frame: continously during treatment
Contacts:
  • GSK Clinical Trials; GlaxoSmithKline (Study Director)
Location Country Status
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, 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, Kansas United States
Kansas Medical Clinic Topeka, Kansas United States
Derm Research, PLLC Louisville, Kentucky United States
Dermatology Specialists 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
Mount Sinai School of Medicine Clinical Dermatology New York, New York United States
St.Luke's/Roosevelt Hospital Center 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 Airlington, 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
Sponsors:
  • Stiefel, a GSK Company - (Lead Sponsor)
  • Basilea Pharmaceutica - Collaborator

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. Review.
  • 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.
  • Ruzicka T, Lynde CW, Jemec GB, Diepgen T, Berth-Jones J, Coenraads PJ, Kaszuba A, Bissonnette R, Varjonen E, Holló 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. Epub 2008 Feb 21.
Terms
  • vesicular hand eczema
  • pompholyx
  • hyperkeratotic hand eczema
  • retinoid treatment
  • fingertip dermatitis
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