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.
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.


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


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


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
Alitretinoin given at well-tolerated doses induced substantial clearing of chronic hand dermatitis in patients refractory to conventional therapy.
Ruzicka
Thomas
T
Department of Dermatology, Heinrich-Heine University Hospital, Dusseldorf, Germany. ruzicka@uni-duesseldorf.de
Larsen
Frederik Grønhøj
FG
Galewicz
Dorota
D
Horváth
Attila
A
Coenraads
Peter Jan
PJ
Thestrup-Pedersen
Kristian
K
Ortonne
Jean Paul
JP
Zouboulis
Christos C
CC
Harsch
Martin
M
Brown
Thomas C
TC
Zultak
Maurice
M
D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D000077556:Alitretinoin; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006229:Hand Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D000305:Adrenal Cortex Hormones; D000077556:Alitretinoin; D014212:Tretinoin