Efficacy and safety of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis: a randomized, double-blind trial.
BACKGROUND
Chronic hand dermatitis is common and difficult to treat.


OBJECTIVE
Our aim was to assess the efficacy of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis.


METHODS
Adult patients (n = 652) were randomized to pimecrolimus 1% or vehicle cream twice daily with overnight occlusion for 6 weeks, followed by a 6-week open-label pimecrolimus treatment. Primary efficacy was 5-point Investigators' Global Assessment of prospectively selected 'target hand' as treatment success (Investigators' Global Assessment 0 or 1) and treatment failure. Pruritus relief was also assessed.


RESULTS
Following double-blind phase treatment, target hand treatment success was achieved in 29.8 and 23.2% of the patients in the pimecrolimus and vehicle groups, respectively (p = 0.057). The proportion of patients experiencing pruritus relief was significantly higher in the pimecrolimus group compared to the vehicle group at all time points throughout the double-blind phase.


CONCLUSIONS
The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group.
Hordinsky
Maria
M
University of Minnesota School of Medicine, Department of Dermatology, Minneapolis, MN 55455, USA. hordi001@umn.edu
Fleischer
Alan
A
Rivers
Jason K
JK
Poulin
Yves
Y
Belsito
Donald
D
Hultsch
Thomas
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004643:Emollients / Q000627:therapeutic use; D005260:Female; D006229:Hand Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000188:drug therapy; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D003879:Dermatologic Agents; D004643:Emollients; C117268:pimecrolimus; D016559:Tacrolimus