Efficacy and Safety of Topical Tacrolimus Microemulsion Applied Twice Daily in Patients with Mild to Moderate Scalp Psoriasis

Abstract

Introduction: Involvement of the scalp is common in psoriasis and severely affects the quality of life of those affected. It is difficult to treat and places special demands on the galenics of a drug formulation. Tacrolimus is a calcineurin inhibitor and is approved as an ointment formulation for the treatment of atopic dermatitis. The efficacy and safety of topically applied tacrolimus have also been studied and proven for psoriasis. However, no proprietary pharmaceutical product is currently approved for this indication.

Methods: A multicenter, double-blind, vehicle-controlled phase 3 study was conducted to evaluate the efficacy and safety of 0.1% tacrolimus microemulsion when applied topically twice daily in 128 patients independently of sex with scalp psoriasis.

Results: The primary efficacy analysis showed a scalp Investigator Global Assessment (s-IGA) of 0 (absence of disease) or 1 (very mild disease) at 8 weeks in 28.6% of subjects in the tacrolimus group, indicating a significantly better response (p = 0.0476, chi-square test) versus 12.7% of subjects in the placebo group (difference of 15.9%-points). The Dermatology Life Quality Index (DLQI) improved over time and was more pronounced in the group treated with tacrolimus-containing microemulsion than in the placebo group, but showed no statistically significant difference after 8 weeks of use (p = 0.193, ANCOVA). The safety analysis revealed no evidence of cutaneous side effects other than those known. Toxicologically relevant serum levels of tacrolimus could be excluded.

Conclusion: The study data show that 0.1% tacrolimus microemulsion has good efficacy and safety in the treatment of scalp psoriasis.

Keywords: Microemulsion; Scalp psoriasis; Tacrolimus; Topical application.

Fig. 1

Number of subjects with a response of 0 or 1 in s-IGA over time (“verum” means the treatment group). s-IGA scalp Investigator Global Assessment

Fig. 2

Percentage of subjects in s-IGA Score at baseline and the end of treatment