0.3% Tacrolimus gel and 0.5% Tacrolimus cream show efficacy in mild to moderate plaque psoriasis: Results of a randomized, open-label, observer-blinded study.
The efficacy and safety of 0.3% tacrolimus gel and 0.5% tacrolimus cream compared with calcipotriol ointment were evaluated in adults (n = 124) with mild to moderate plaque psoriasis. Treatment was twice daily for a maximum of 12 weeks. Clinical efficacy was assessed by the percentage change in the local psoriasis severity index of a target lesion between baseline and week 12. By week 12, the median percentage changes in local psoriasis severity index of the target lesions in the tacrolimus gel, tacrolimus cream and calcipotriol groups were 55.6%, 50.0% and 58.6%, respectively (no statistically significant differences). Clinical improvement was observed after one week and increased throughout the study. Tacrolimus-treated patients experienced more application site skin burning (tacrolimus gel and cream both 31.0% versus 7.5% for calcipotriol; p = 0.011). Skin burning was mostly mild in intensity and decreased substantially after 1 week of treatment. There were no differences in the nature and incidence of infections and no clinically relevant changes in laboratory values.
Service de Dermatologie, Hôpital Archet 2, Nice, France. jean-paul.ortonne@unice.fr
Jean-Paul
JP
Ortonne
Peter C M
PC
van de Kerkhof
Jörg C
JC
Prinz
Thomas
T
Bieber
Morad
M
Lahfa
Andris
A
Rubins
Gottfried
G
Wozel
Gérard
G
Lorette
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002117:Calcitriol / Q000031:analogs & derivatives / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D005782:Gels; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D003879:Dermatologic Agents; D005782:Gels; D007166:Immunosuppressive Agents; D009824:Ointments; C055085:calcipotriene; D002117:Calcitriol; D016559:Tacrolimus