Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
1 other identifier
interventional
250
3 countries
33
Brief Summary
Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2006
Shorter than P25 for phase_3
33 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
March 30, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMay 10, 2023
May 1, 2023
1 year
March 30, 2006
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Safety:
Adverse Events
Safety Laboratory
Radiological investigations (bone density, x-ray)
Secondary Outcomes (4)
Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids
You may not qualify if:
- female of childbearing potential, unless participating in a pregnancy prevention program
- psoriasis
- active major psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Edmonton, Alberta, T6G2G3, Canada
Unknown Facility
Vancouver, British Columbia, V5O3Y1, Canada
Unknown Facility
Winnipeg, Manitoba, R3C1R4, Canada
Unknown Facility
Hawkesbury, Ontario, K6A1A1, Canada
Unknown Facility
London, Ontario, N6H1S9, Canada
Unknown Facility
Markham, Ontario, L3P1A8, Canada
Unknown Facility
Oakville, Ontario, L6J7W5, Canada
Unknown Facility
Montreal, Quebec, H3X1V6, Canada
Unknown Facility
Sheerbroke, Quebec, J1H1Z1, Canada
Unknown Facility
Québec, G1J1X7, Canada
Unknown Facility
Berlin, 12353, Germany
Unknown Facility
Berlin, 13439, Germany
Unknown Facility
Cologne, 51143, Germany
Unknown Facility
Frankfurt, 60326, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Hamburg, 20354, Germany
Unknown Facility
Hamburg, 22143, Germany
Abt. Klinische Sozialmedizin
Heidelberg, 69115, Germany
Unknown Facility
Ibbenbueren, 49477, Germany
Unknown Facility
Lübeck, 23558, Germany
Unknown Facility
Mönchengladbach, 41061, Germany
Unknown Facility
München, 81375, Germany
Unknown Facility
Münster, 48143, Germany
Unknown Facility
Osnabrück, 49078, Germany
Unknown Facility
Potsdam, 14482, Germany
Unknown Facility
Viersen, 41747, Germany
Unknown Facility
Wuppertal, 42275, Germany
Unknown Facility
Gdansk, Poland
Unknown Facility
Krakow, 31-462, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Opole, 45-372, Poland
Unknown Facility
Szcecin, Poland
Unknown Facility
Wroclaw, Poland
Related Publications (2)
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. doi: 10.1001/archderm.140.12.1453.
PMID: 15611422BACKGROUNDBlome C, Maares J, Diepgen T, Jeffrustenbach S, Augustin M. Measurement of patient-relevant benefits in the treatment of chronic hand eczema--a novel approach. Contact Dermatitis. 2009 Jul;61(1):39-45. doi: 10.1111/j.1600-0536.2009.01536.x.
PMID: 19659963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Diepgen, MD
Univ. Heidelberg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2006
First Posted
April 3, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2007
Study Completion
May 1, 2007
Last Updated
May 10, 2023
Record last verified: 2023-05