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.