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
Study complete
Study complete
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:
Enrollment:
599
Primary completion date:
2012-26-04
Observational study model:
Not applicable
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
Showing 1 - 6 of 70 Results
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
Study complete
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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