Efficacy of 0.1% tacrolimus ointment in chronic plaque psoriasis: A randomized double-blind placebo-controlled study

Abstract

Background and Design: Despite the development of effective systemic treatments and new biological agents for psoriasis nowadays, topical medications are still the mainstay of treatment. Topical calcineurin inhibitors are currently used in various skin diseases. We investigated the efficacy and safety of tacrolimus, which is an alternative in topical treatment, in comparison with the present medications in plaque psoriasis.Materials and Methods: This prospective double-blind placebo-controlled study was conducted in 24 patients with the diagnosis of plaque psoriasis who were seen in Uludag University Hospital dermatology outpatient clinic. 0.1% tacrolimus ointment, 0.1% mometasone furoate ointment, 0.005% calcipotriol ointment and placebo in encrypted bottles were randomly applied under occlusion to 27 psoriatic plaques in test chambers, every other day, for a period of 19 days. Clinic sum scores, side effects, and epidermal thickness measured by superficial ultrasound were noted before and after treatment in all microplaques. Besides, histopathologic scoring and epidermal thickness were measured in 9 patients at the end of the study.Results: The clinic sum scores and ultrasonographic epidermal thickness at the end were both significantly lower than the beginning values in all microplaques (p<0.05). The reduction in these two values with tacrolimus were significantly higher than that with placebo (p<0.001), but no difference was observed with calcipotriol (p=0.287, p=0.813, respectively). On the other hand, the reduction in these values with mometasone was significantly higher than with tacrolimus (p<0.05). Mometasone furoate was the most effective when the three ointments were compared with placebo in terms of total histopathological score and epidermal thickness.Conclusion: Tacrolimus ointment applied under occlusion is an alternative topical medication in the treatment of plaque psoriasis. Occlusion in practice requires patient compliance. Thus, studies to find a new formulation that will increase absorption of drug from thick psoriatic plaques are needed.