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The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.
Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alitretinoin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Physicians global assessment | ||
| at week 12 or 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate per treatment group | ||
| Modified total lesion symptom score | ||
| Patients global assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ruzicka, MD | University of Düsseldorf, Dermatological Hospital, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Ruzicka, MD | Düsseldorf | 40225 | Germany |
| 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. |
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| 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 |
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| at week 12 or 24 |
| Time to relapse |
| 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 |