Topical Tacrolimus Is Not Effective in Chronic Plaque Psoriasis

Abstract

Background: Cyclosporine for the treatment of psoriasis constitutes a new approach. Alternative systemic cyclosporine derivatives have been studied to find an immunosuppressive drug with fewer adverse effects. Tacrolimus is one of these new immunosuppressive drugs. Systemically, it has been proven effective in treating psoriasis. A topical formulation of tacrolimus is attractive because it has fewer adverse effects and is useful for a large group of patients. We report for the first time on the efficacy of nonocclusive topical tacrolimus in the treatment of psoriasis. Observations: After a washout phase of 2 weeks, patients were randomized to receive 0.005% calcipotriol ointment twice daily, placebo ointment once daily, or 0.3% tacrolimus ointment once daily. One psoriatic plaque was treated with a surface area of 40 to 200 cm 2. Efficacy was estimated using the local psoriasis severity index. The reduction in the local psoriasis severity index score after 6 weeks was 62.5% in the calcipotriol group, 33.3% in the tacrolimus group, and 42.9% in the placebo group. Conclusions: There was no statistically significant difference between the efficacy of tacrolimus and placebo ointment (P = .77). Calcipotriol ointment, applied twice daily, had a better effect than tacrolimus ointment and placebo ointment once daily.

Effects of nanoparticles with hydrotropic nicotinamide on tacrolimus: permeability through psoriatic skin and antipsoriatic and antiproliferative activities

“…21 However, topical application of the commercial ointment failed to promote FK506 deposition in hyperkeratotic psoriatic plaques. 22 Meanwhile, FK506 ointment is difficult to be washed off from the skin surface and may create a sticky sense and discomfort to the patient due to its greasy nature. Several reports demonstrated that topical application of FK506 ointment was only effective under occlusion or to some specific regions of the body where the skin was thinner and more permeable, such as the face and intertriginous areas.…”

The 500 Dalton rule for the skin penetration of chemical compounds and drugs

“…There is one abstract indicating its efficacy in psoriasis when applied under occlusion (12). A controlled study could not detect efficacy in an open application approach (13). Ascomycin derivatives have also been tested for possible topical efficacy.…”

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

“…Psoriasiste yapılan ilk randomize çalışmada takrolimusun plaseboya üstünlüğü gösterilememiştir 12 . Yazarlar bu sonucu ilacın günde bir kere ve oklüzyonsuz uygulanmasına bağlamıştır.…”

“…Psoriasiste topikal takrolimusun etkinliğinin değerlendirildiği çalışmalarda özellikle fasiyal, invers ve genital psoriasiste başarılı sonuçlar bildirilmiştir [5][6][7][8][9] . Bunun yanında kronik plak tipi psoriasiste etkinliği plaseboya benzer, plasebodan üstün ve potent steroidlere eşdeğer şeklinde çelişkili sonuçlar bildirilmektedir [10][11][12] . Son yıllarda topikal takrolimus tırnak tutulumunda da etkili olarak bildirilmiştir 13 .…”