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

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

Research output: Contribution to journalArticle

107 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1453-1459
Number of pages7
JournalArchives of Dermatology
Volume140
Issue number12
DOIs
Publication statusPublished - Dec 2004

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Dermatitis
Multicenter Studies
Hand
Placebos
Therapeutics
Safety
Ambulatory Care Facilities
Hyperlipidemias
Thyroxine
Signs and Symptoms
Headache
alitretinoin
Hemoglobins
Outcome Assessment (Health Care)
Physicians
Recurrence

ASJC Scopus subject areas

  • Dermatology

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

In: Archives of Dermatology, Vol. 140, No. 12, 12.2004, p. 1453-1459.

Research output: Contribution to journalArticle

Ruzicka, Thomas ; Larsen, Frederik Grønhøj ; Galewicz, Dorota ; Horváth, A. ; Coenraads, Peter Jan ; Thestrup-Pedersen, Kristian ; Ortonne, Jean Paul ; Zouboulis, Christos C. ; Harsch, Martin ; Brown, Thomas C. ; Zultak, Maurice. / 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. In: Archives of Dermatology. 2004 ; Vol. 140, No. 12. pp. 1453-1459.
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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.",
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AU - Larsen, Frederik Grønhøj

AU - Galewicz, Dorota

AU - Horváth, A.

AU - Coenraads, Peter Jan

AU - Thestrup-Pedersen, Kristian

AU - Ortonne, Jean Paul

AU - Zouboulis, Christos C.

AU - Harsch, Martin

AU - Brown, Thomas C.

AU - Zultak, Maurice

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N2 - 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.

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