This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (18)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Dermatologic Disorders  • Randomized Controlled Trial  • Dermatologic Disorders, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

Results of a Randomized, Double-blind, Placebo-Controlled, Multicenter Trial

Thomas Ruzicka, MD; Frederik Grønhøj Larsen, MD, PhD; Dorota Galewicz, MD; Attila Horváth, MD; Peter Jan Coenraads, MD; Kristian Thestrup-Pedersen, MD; Jean Paul Ortonne, MD; Christos C. Zouboulis, MD; Martin Harsch, PhD; Thomas C. Brown, PhD; Maurice Zultak, MD

Arch Dermatol. 2004;140:1453-1459.

Objective  To assess the efficacy and safety of oral alitretinoin (9-cis-retinoic acid), 10 mg/d, 20 mg/d, and 40 mg/d, compared with placebo control, in the treatment of chronic hand dermatitis.

Design  Multicenter, randomized, double-blind, placebo-control, prospective trial.

Setting  A total of 43 outpatient clinics in 10 European countries.

Patients  Of 348 patients screened, 319 with moderate or severe refractory chronic hand dermatitis were randomized, in the ratio of 1:1:1:1, to 4 treatment groups and received allocated intervention. Of 75 patients who withdrew, 24 withdrew owing to adverse events.

Interventions  Placebo or 10 mg, 20 mg, or 40 mg of oral alitretinoin (9-cis-retinoic acid) taken once daily for 12 weeks. Safety was assessed for all patients during a follow-up period of 4 weeks, and responders were observed for a follow-up period of 3 months.

Main Outcome Measure  Physician’s global assessment of overall chronic hand dermatitis severity.

Results  Alitretinoin led to a significant and dose-dependent improvement in disease status, with responses in up to 53% of patients, and up to a 70% mean reduction in disease signs and symptoms. Treatment was generally well tolerated, with dose-dependent effects comprising headache, flushing, mucocutaneous events, hyperlipidemia, and decreased hemoglobin and decreased free thyroxin levels. Three months after discontinuation of treatment, the rate of relapse was 26%, independent of dose.

Conclusion  Alitretinoin given at well-tolerated doses induced substantial clearing of chronic hand dermatitis in patients refractory to conventional therapy.

Author Affiliations: Heinrich-Heine University Hospital, Dusseldorf, Germany (Dr Ruzicka); Hørsholm Sygehus, Hørsholm, Denmark (Dr Larsen); Outpatient Clinic, Plock, Poland (Dr Galewicz); National Institute for Dermatology, Budapest, Hungary (Dr Horváth); Academic Hospital, Groningen, the Netherlands (Dr Coenraads); Marselisborg Hospital, University of Aarhus, Aarhus, Denmark (Dr Thestrup-Pedersen); University Hospital L’Archet, Nice, France (Dr Ortonne); University Medical Center Benjamin Franklin, Berlin, Germany (Dr Zouboulis); and Basilea Pharmaceutica Ltd, Basel, Switzerland (Drs Harsch, Brown, and Zultak).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Alitretinoin as a potential advance in the management of severe chronic hand eczema.
Ingram et al.
Arch Dermatol 2009;145:314-315.
FULL TEXT