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.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adrenal Cortex Hormones / administration & dosage
  • Adrenal Cortex Hormones / therapeutic use
  • Alitretinoin
  • Chronic Disease
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Resistance
  • Female
  • Follow-Up Studies
  • Hand Dermatoses / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Recurrence
  • Treatment Outcome
  • Tretinoin / administration & dosage*
  • Tretinoin / adverse effects
  • Tretinoin / therapeutic use


  • Adrenal Cortex Hormones
  • Alitretinoin
  • Tretinoin