Tacrolimus ointment in nickel sulphate–induced steroid-resistant allergic contact dermatitis

Abstract

Tacrolimus ointment is a topical immunomodulator. Currently, there is available evidence regarding the potential use of topical tacrolimus in a range of dermatological disorders. The aim of this study was to evaluate the efficacy and safety of tacrolimus ointment 0.1% for the nickel sulfate-induced steroid-resistant allergic contact dermatitis (ACD). A randomized, double-blind, placebo-controlled, parallel-group study design was performed in a total of 28 patients affected by nickel sulfate-induced steroid-resistant ACD after a 14-day run-in period. Then, the enrolled patients were randomized into two subgroups. Group A was treated with tacrolimus for 14 days and finally observed for a 7-day follow-up period. Group B, instead, was treated with placebo (vehicle). Four major symptoms (erythema, oozing, scaling, and itching) were considered as outcomes during the different phases of the study. In group A, during the treatment period with tacrolimus, a significant improvement was observed in all four considered symptoms. On the other hand, no improvement in symptoms was observed in the placebo-treated group B. Local adverse events in the tacrolimus-treated group, such as burning/itching at the application site, were transient and well tolerated. No patients withdrew because of burning/itching. In our study, tacrolimus ointment 0.1% appeared to be both effective and safe in the treatment of nickel sulfate-induced steroid-resistant ACD.

Tacrolimus ointment 0.1% in the treatment of allergic contact eyelid dermatitis

“…A recent, doubleblind, placebo-controlled, randomized study in 28 patients with steroid-resistant allergic contact dermatitis to nickel demonstrated significant improvement by 2 weeks of topical tacrolimus therapy. 21 Topical application of the drug to the eyelids and periocular skin was well tolerated. Transient burning and itching was reported by 10% of the patients in the study and this is in accordance with most other studies, which suggest excellent patient tolerance to the drug.…”

“…We did not observe any further improvement for the physician‐graded parameters at the end of 60 days, as compared to 30 days of treatment. A recent, double‐blind, placebo‐controlled, randomized study in 28 patients with steroid‐resistant allergic contact dermatitis to nickel demonstrated significant improvement by 2 weeks of topical tacrolimus therapy 21 …”

Guidelines for diagnosis, prevention, and treatment of hand eczema

“…The 2019 Cochrane review on HE included four small studies on tacrolimus (107 participants in total) and five larger studies on pimecrolimus (1059 participants), all of rather short duration (≤8 weeks) 1 . Tacrolimus 0.1% ointment probably improves investigator‐rated symptom control measured after 3 weeks compared to vehicle (14/14 tacrolimus vs 0/14 vehicle) 162 . Participant‐rated symptoms were not measured.…”

Off-Label Use of Topical Calcineurin Inhibitors in Dermatologic Disorders

“…35,36 Two small RCTs support the use of tacrolimus 0.1% ointment in the treatment of moderateto-severe hand dermatitis as an adjunct to an oral prednisone-tapering strategy 37 and for the treatment of dyshidrotic palmar eczema. 38 The efficacy of topical tacrolimus for the treatment of allergic contact dermatitis induced by various allergens is supported by 3 double-blind, vehicle-controlled RCTs [39][40][41] and 2 comparative trials against TCS. 42,43 One small (n=12) open-label trial suggests pimecrolimus was no more effective than placebo for the treatment of allergic contact dermatitis induced by poison ivy.…”