Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids
| Autor: | T. C. Brown, Gregor B.E. Jemec, Robert Bissonnette, Charles Lynde, M Harsch, Filippa Nyberg, Åke Svensson, J. Maares, P Hollo, Thomas L. Diepgen, Thomas Ruzicka, E. Varjonen, P.-J. Coenraads, Frédéric Cambazard, M Lahfa, J. Berth-Jones, Peter Elsner, A Kaszuba |
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| Přispěvatelé: | Faculteit Medische Wetenschappen/UMCG, Science in Healthy Ageing & healthcaRE (SHARE), Public Health Research (PHR) |
| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization Adolescent Tretinoin Dermatology Hand Dermatoses Placebo law.invention 030207 dermatology & venereal diseases 03 medical and health sciences Alitretinoin 0302 clinical medicine Randomized controlled trial Refractory law QUALITY-OF-LIFE Internal medicine Outpatient clinic Medicine Humans Adverse effect Aged Dose-Response Relationship Drug business.industry CONTACT-DERMATITIS Drug Administration Routes alitretinoin Middle Aged 3. Good health Surgery PREVALENCE Clinical trial 9-cis-retinoic acid 030220 oncology & carcinogenesis Chronic Disease randomized controlled trial Female Dermatologic Agents eczema business Epidemiologic Methods medicine.drug |
| Zdroj: | BRITISH JOURNAL OF DERMATOLOGY, 158(4), 808-817. Wiley |
| ISSN: | 0007-0963 |
| Popis: | Background Patients with severe chronic hand eczema (CHE) refractory to topical corticosteroids currently have limited treatment options suited for chronic use, and few controlled clinical studies have investigated new therapies in this setting.Objectives To assess the efficacy and safety of oral alitretinoin (9-cis retinoic acid) taken at 10 mg or 30 mg once daily for up to 24 weeks, compared with placebo control, in the treatment of severe CHE refractory to topical corticosteroids.Methods A randomized, double-blind, placebo-controlled, prospective, multicentre trial was conducted in 111 dermatology outpatient clinics in Europe and Canada. A total of 1032 patients with severe refractory CHE were randomized in a 1 : 2 : 2 ratio to placebo, or 10 mg or 30 mg of oral alitretinoin once daily for up to 24 weeks. Safety was assessed for all patients during a follow-up period of 4 weeks, and responders were observed for relapse for 24 weeks after the end of therapy. The primary efficacy parameter was Physician Global Assessment of overall CHE severity, with response defined as clear or almost clear hands.Results Responses, defined as clear or almost clear hands, were achieved in up to 48% of patients treated with alitretinoin, compared with 17% for placebo (P Conclusions Alitretinoin given at well-tolerated doses induced clearing of CHE in a substantial proportion of patients with severe disease refractory to standard therapy. |
| Databáze: | OpenAIRE |
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