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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.
For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.
Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.
This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alitretinoin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: | ||
| Adverse Events | ||
| Safety Laboratory | ||
| Radiological investigations (bone density, x-ray) |
| Measure | Description | Time Frame |
|---|---|---|
| Physicians Global Assessment | ||
| modified Total Lesion Symptom Score | ||
| Patients Global Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Diepgen, MD | Univ. Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | T6G2G3 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15611422 | Background | 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. | |
| 19659963 |
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| Patient Defined Outcomes |
| Vancouver |
| British Columbia |
| V5O3Y1 |
| Canada |
| Winnipeg | Manitoba | R3C1R4 | Canada |
| Hawkesbury | Ontario | K6A1A1 | Canada |
| London | Ontario | N6H1S9 | Canada |
| Markham | Ontario | L3P1A8 | Canada |
| Oakville | Ontario | L6J7W5 | Canada |
| Montreal | Quebec | H3X1V6 | Canada |
| Sheerbroke | Quebec | J1H1Z1 | Canada |
| Québec | G1J1X7 | Canada |
| Berlin | 12353 | Germany |
| Berlin | 13439 | Germany |
| Cologne | 51143 | Germany |
| Frankfurt | 60326 | Germany |
| Hamburg | 20246 | Germany |
| Hamburg | 20354 | Germany |
| Hamburg | 22143 | Germany |
| Abt. Klinische Sozialmedizin | Heidelberg | 69115 | Germany |
| Ibbenbueren | 49477 | Germany |
| Lübeck | 23558 | Germany |
| Mönchengladbach | 41061 | Germany |
| München | 81375 | Germany |
| Münster | 48143 | Germany |
| Osnabrück | 49078 | Germany |
| Potsdam | 14482 | Germany |
| Viersen | 41747 | Germany |
| Wuppertal | 42275 | Germany |
| Gdansk | Poland |
| Krakow | 31-462 | Poland |
| Lublin | Poland |
| Opole | 45-372 | Poland |
| Szcecin | Poland |
| Wroclaw | Poland |
| Derived |
| Blome 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. |
| ID | Term |
|---|---|
| D006229 | Hand Dermatoses |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077556 | Alitretinoin |
| ID | Term |
|---|---|
| D014212 | Tretinoin |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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