Topical tacrolimus 0.1% improves symptoms of hand dermatitis in patients treated with a prednisone taper.

BACKGROUND

Hand dermatitis is a chronic inflammatory skin disorder for which systemic immunosuppressive therapy is often needed. Topical treatments could complement the use of systemic corticosteroids.

OBJECTIVE

To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical tacrolimus 0.1% ointment versus vehicle.

METHODS

Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any occurrence of relapse was recorded by patients.

RESULTS

Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus versus vehicle was 48 versus 39 days, respectively (P = .78). A greater improvement of induration (P = .003) and scaling (P = .003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week 1 to week 12 (P = .04) compared to vehicle. Improvement in erythema (P < .0001), fissuring (P = .0003), pruritus (P = .06), and investigator's global assessment (P < .0001) with tacrolimus was not found to exceed improvement with vehicle.

LIMITATIONS: Small sample size provides limited power to detect differences in response.

CONCLUSIONS

Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to recurrence.