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Arch Dermatol. 2004 Dec;140(12):1453-9.

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.

Author information

1
Department of Dermatology, Heinrich-Heine University Hospital, Dusseldorf, Germany. ruzicka@uni-duesseldorf.de

Abstract

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.

PMID:
15611422
DOI:
10.1001/archderm.140.12.1453
[Indexed for MEDLINE]

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