Last updated: 04/10/2020 18:40:05
Efficacy and safety of a retinoid in the treatment of severe chronic hand eczemaHANDEL
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Efficacy and safety of alitretinoin in the treatment of severe chronic hand eczema refractory to topical therapy
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants who responded as per Physician's Global Assessment (PGA) at Week 24
Timeframe: Week 24 (end-of-treatment)
Secondary outcomes:
Percentage change from Baseline in modified total lesion symptom score (mTLSS) at the end-of-treatment
Timeframe: Baseline (Week 0) and Week 24 (end-of-treatment)
Number of participants who responded as per Patient Global Assessment (PaGA) at end-of-treatment
Timeframe: Week 24 (end-of-treatment)
Percentage change from Baseline in extent of disease at end-of-treatment
Timeframe: Baseline (Week 0) and Week 24 (end-of-treatment)
Response duration for responding participants at the end-of-therapy
Timeframe: 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
Timeframe: Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)
Time to response for responding participants at end-of-therapy
Timeframe: Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)
Number of participants with adverse events (AEs) and serious adverse events (SAEs) during the treatment period
Timeframe: Up to Week 24 (end-of-treatment)
Number of participants with maximum post Baseline laboratory values outside the marked reference range
Timeframe: Up to Week 28
Number of participants referred or not referred to a psychiatrist as per brief summary inventory (BSI) 53 questionnaire up to 24 weeks
Timeframe: Up to Week 24
Change from Baseline in Patient Health Questionnaire (PHQ-9) score over 28 weeks
Timeframe: Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24, 28
Number of participants meeting the referral criteria of psychiatric evaluation over 28 weeks
Timeframe: Up to 28 Weeks
Change from Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) over 24 weeks
Timeframe: Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24
Change from Baseline in Dizziness Handicap Inventory (DHI) over 24 weeks
Timeframe: Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24
Number of participants responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) questionnaire over 24 weeks
Timeframe: Up to Week 24
Percent change from Baseline in Bone Mineral Density (BMD) by Dual energy X-ray absorptiometry (DXA) over 72 weeks
Timeframe: Baseline (Week 0) and Week 72
Number of participants with adequecy of images assessed by X-ray evaluation of bones
Timeframe: Up to Week 72
Number of participants with adverse ophthalmological change as assessed by Fundus Photography - Intraocular Pressure
Timeframe: Up to Week 24
Number of participants with adverse audiological change as assessed by Puretone Audiogram at Highest Frequency
Timeframe: Up to Week 24
Interventions:
Drug: alitretinoin
Drug: Placebo
Enrollment:
599
Observational study model:
Not applicable
Primary completion date:
2012-26-04
Time perspective:
Not applicable
Clinical publications:
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, Horváth 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. doi: 10.1111/j.1365-2133.2008.08487.x. Epub 2008 Feb 21.
Joseph Fowler, Ole Graff, Abbasali Hamedani . 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;13(10):1198-1204.
Medical condition
Eczema
Product
alitretinoin
Collaborators
Basilea Pharmaceutica
Study date(s)
January 2009 to April 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
- rated as severe by the physician
- 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
Inclusion and exclusion 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
Trial location(s)
Location
Western State Clinical Research Inc.
Wheat Ridge, CO, United States, 80033
Status
Recruitment Complete
Location
Dermatology Research Associates
Los Angeles, CA, United States, 90045
Status
Recruitment Complete
Location
Dartmouth-Hitchcock Medical Center
Lebanon, NH, United States, 03756
Status
Recruitment Complete
Location
Premier Clinical Research
Seattle, WA, United States, 99204
Status
Recruitment Complete
Location
Dermatology and Laser Center NW
Bellingham, WA, United States, 98281
Status
Recruitment Complete
Location
Hamzavi Dermatology Clinic
Fort Gratiot, MI, United States, 48059
Status
Recruitment Complete
Location
Washington University Dermatology Research
St.Louis, MO, United States, 63110
Status
Recruitment Complete
Location
East Bay Psoriasis Treatment Center
San Ramon, CA, United States, 94583
Status
Recruitment Complete
Location
Modern Research Associates
Dallas, TX, United States, 75231
Status
Recruitment Complete
Location
UMDNJ - Robert Wood Johnson School of Medicine, Dermatology
Somerset, NJ, United States, 08873
Status
Recruitment Complete
Location
Oregon Dermatology and Research Center
Portland, OR, United States, 97210
Status
Recruitment Complete
Location
The Dermatology Center
New Albany, IN, United States, 47150
Status
Recruitment Complete
Location
Dermatology Research of Arkansas
Little Rock, AR, United States, 72205
Status
Recruitment Complete
Location
Derm Research Center of New York Inc.
Stony Brook, NY, United States, 11790
Status
Recruitment Complete
Location
Solano Clinical Research, Dow Pharmaceutical Sciences
Vallejo, CA, United States, 94589
Status
Recruitment Complete
Location
Therapeutics Clinical Research
San Diego, CA, United States, 92123
Status
Recruitment Complete
Location
University of California, Davis
Sacramento, CA, United States, 95816
Status
Recruitment Complete
Location
Bernstein Clinical Research Center
Cincinnati, OH, United States, 45242
Status
Recruitment Complete
Location
Indiana University Dermatology
Indianapolis, IN, United States, 37660
Status
Recruitment Complete
Location
Mount Sinai School of Medicine Clinical Dermatology
New York, NY, United States, 10029
Status
Recruitment Complete
Location
Park Avenue Dermatology, PA
Orange Park, FL, United States, 32073
Status
Recruitment Complete
Location
Fletcher Allen Health Care
Burlington, VT, United States, 05401
Status
Recruitment Complete
Location
Oregon Health and Science University
Portland, OR, United States, 97239
Status
Recruitment Complete
Location
St.Luke's/Roosevelt Hospital Center
New York, NY, United States, 10025
Status
Recruitment Complete
Location
Center for Clinical Studies
Houston, TX, United States, 77030
Status
Recruitment Complete
Location
Minnesota Clinical Studies Research Center
Fridley, MN, United States, 55432
Status
Recruitment Complete
Location
Grekin Skin Institute
Warren, Michigan, United States, 48088
Status
Recruitment Complete
Location
Silverton Skin Institute
Grand Blanc, MI, United States, 48439
Status
Recruitment Complete
Location
Toccoa Clinic Medical Associates
Toccoa, GA, United States, 30577
Status
Recruitment Complete
Location
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Status
Recruitment Complete
Location
MAPS Applied Research Center
Edina, MN, United States, 55435
Status
Recruitment Complete
Location
Academy of Clinical Research
Airlington, TX, United States, 76011
Status
Recruitment Complete
Location
Paddington Testing Co.Inc
Philadelphia, PA, United States, 19103
Status
Recruitment Complete
Location
Madison Skin & Research Inc.
Madison, WI, United States, 53719
Status
Recruitment Complete
Location
Kansas City Dermatology, PA
Overland Park, KS, United States, 66215
Status
Recruitment Complete
Location
University of Alabama, Birmingham
Birmingham, AL, United States, 35233
Status
Recruitment Complete
Location
American Dermatology Association
Shawnee, Kansas, United States, 66216
Status
Recruitment Complete
Location
Dermatology Associates of Kingsport
Kingsport, TN, United States, 37660
Status
Recruitment Complete
Location
University of California, San Diego Dermatology Clinical Trials Unit
La Jolla, CA, United States, 92037
Status
Recruitment Complete
Location
Dermatology Clinical Research Center of San Antonio
San Antonio, TX, United States, 77056
Status
Recruitment Complete
Location
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield, IN, United States, 46168
Status
Recruitment Complete
Location
Center for Clinical Studies
Webster, TX, United States, 77598
Status
Recruitment Complete
Location
Shahram Jacobs, MD, Inc.
Encino, CA, United States, 91436
Status
Recruitment Complete
Location
Laser and Dermatology Center
Marina del Rey, CA, United States, 90292
Status
Recruitment Complete
Location
Helendale Dermatology and Medical Spa
Rochester, New York, United States, 14609
Status
Recruitment Complete
Location
Azalea Research Center
Wilmington, NC, United States, 28403
Status
Recruitment Complete
Location
Integrated Research Group
Riverside, CA, United States, 92506
Status
Recruitment Complete
Location
Michael Bukhalo MD
Arlington Heights, IL, United States, 60005
Status
Recruitment Complete
Location
Palm Beach Research Center
West Palm Beach, FL, United States, 33409
Status
Recruitment Complete
Location
George Washington University - Medical Faculty Associates
Washington, DC, United States, 20037
Status
Recruitment Complete
Location
South Lincoln Dermatology
Lincoln, NE, United States, 68502
Status
Recruitment Complete
Location
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Status
Recruitment Complete
Location
Deaconess Clinic, Inc.
Evansville, IN, United States, 47713
Status
Recruitment Complete
Location
Wake Forrest University School of Medicine
Winston-Salem, NC, United States, 27157
Status
Recruitment Complete
Location
Schaumburg Dermatology
Schaumburg, IL, United States, 60194
Status
Recruitment Complete
Location
University of North Carolina, Dermatology Department
Chapel Hill, NC, United States, 918-843-9447
Status
Recruitment Complete
Location
Rhode Island Hospital
Providence, RI, United States, 02903
Status
Recruitment Complete
Location
Stanford University Dept of Dermatology
Stanford, CA, United States, 94305
Status
Recruitment Complete
Location
Tennessee Clinical Research Center
Nashville, TN, United States, 37215
Status
Recruitment Complete
Location
University of Pittsburgh Medical Center
Pittsburgh, PA, United States, 15213
Status
Recruitment Complete
Location
Virginia Clinical Research Inc.
Norfolk, VA, United States, 23507
Status
Recruitment Complete
Location
Tulane University Health Sciences, Dermatology Dept
New Orleans, LA, United States, 70112
Status
Recruitment Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-26-04
Actual study completion date
2012-26-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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