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| Sponsored by: |
Basilea Pharmaceutica |
|---|---|
| Information provided by: | Basilea Pharmaceutica |
| ClinicalTrials.gov Identifier: | NCT00309621 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hand Dermatoses |
Drug: alitretinoin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis |
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada | |
| Quebec, Canada, G1J1X7 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G2G3 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5O3Y1 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3C1R4 | |
| Canada, Ontario | |
| Markham, Ontario, Canada, L3P1A8 | |
| Oakville, Ontario, Canada, L6J7W5 | |
| London, Ontario, Canada, N6H1S9 | |
| Hawkesbury, Ontario, Canada, K6A1A1 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3X1V6 | |
| Sheerbroke, Quebec, Canada, J1H1Z1 | |
| Germany | |
| Abt. Klinische Sozialmedizin | |
| Heidelberg, Germany, 69115 | |
| München, Germany, 81375 | |
| Berlin, Germany, 12353 | |
| Köln, Germany, 51143 | |
| Osnabrück, Germany, 49078 | |
| Wuppertal, Germany, 42275 | |
| Berlin, Germany, 13439 | |
| Hamburg, Germany, 20354 | |
| Münster, Germany, 48143 | |
| Mönchengladbach, Germany, 41061 | |
| Hamburg, Germany, 22143 | |
| Potsdam, Germany, 14482 | |
| Lübeck, Germany, 23558 | |
| Viersen, Germany, 41747 | |
| Hamburg, Germany, 20246 | |
| Ibbenbüren, Germany, 49477 | |
| Frankfurt, Germany, 60326 | |
| Poland | |
| Krakow, Poland, 31-462 | |
| Gdansk, Poland | |
| Opole, Poland, 45-372 | |
| Wroclaw, Poland | |
| Szcecin, Poland | |
| Lublin, Poland | |
| Principal Investigator: | Thomas Diepgen, MD | Univ. Heidelberg |
More Information
| Study ID Numbers: | BAP00626 |
| Study First Received: | March 30, 2006 |
| Last Updated: | January 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00309621 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada; Poland: Ministry of Health |
|
Hand Dermatoses, hand dermatitis hand eczema chronic hand dermatitis retinoid |
|
Hand Dermatoses Alitretinoin Skin Diseases Skin Abnormalities |
Acrodermatitis Eczema Congenital Abnormalities Dermatitis |
|
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
