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

Abstract

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.

CONCLUSION:

The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group.

• Authors: Maria Hordinsky, Alan Fleischer, Jason K Rivers, Yves Poulin, Donald Belsito, Thomas Hultsch
• Journal: Dermatology (Basel, Switzerland) (Dermatology) Vol. 221 Issue 1 Pg. 71-7 (Aug 2010) ISSN: 1421-9832 [Electronic] Switzerland
• PMID: 20693804 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2010 S. Karger AG, Basel.

Chemical References

• Dermatologic Agents
• Emollients
• pimecrolimus
• Tacrolimus

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Chronic Disease
• Dermatologic Agents (therapeutic use)
• Double-Blind Method
• Emollients (therapeutic use)
• Female
• Hand Dermatoses (drug therapy)
• Humans
• Male
• Middle Aged
• Pruritus (drug therapy)
• Severity of Illness Index
• Tacrolimus (analogs & derivatives, therapeutic use)
• Treatment Outcome
• Young Adult