Comparison of cutaneous tolerance and efficacy of calcitriol 3 microg g(-1) ointment and tacrolimus 0.3 mg g(-1) ointment in chronic plaque psoriasis involving facial or genitofemoral areas: a double-blind, randomized controlled trial.
BACKGROUND
Two nonsteroidal topical agents, calcitriol and tacrolimus, have been reported to be effective and safe for psoriatic lesions on sensitive areas. However, no comparative studies between calcitriol and tacrolimus have been reported.


OBJECTIVE
To compare the tolerability and efficacy of calcitriol 3 microg g(-1) and tacrolimus 0.3 mg g(-1) ointment in chronic plaque psoriasis affecting facial and genitofemoral regions.


METHODS
This is a double-blind, parallel, 6-week study of 50 patients who were randomized in a 1 : 1 ratio to apply calcitriol or tacrolimus twice daily. The primary efficacy variable was the mean reduction of the target area score (TAS), and the secondary efficacy variable was the percentage of patients with the Physician's Global Assessment (PGA) score of 5 (clear) and 4 (almost clear) at the end of the study.


RESULTS
Both calcitriol and tacrolimus were well tolerated. Although calcitriol induced perilesional erythema in a statistically significant higher proportion of patients than tacrolimus (55% vs. 16% at week 6; P < 0.05), it did not necessitate treatment discontinuation. At the end of the study, tacrolimus was significantly more effective than calcitriol based on a significant reduction of mean TAS (67% vs. 51%; P < 0.05) as well as more patients achieving complete or almost complete clearance by PGA (60% vs. 33%; P < 0.05).


CONCLUSIONS
Both calcitriol 3 microg g(-1) and tacrolimus 0.3 mg g(-1) are safe and well-tolerated therapeutic agents in the treatment of psoriasis in sensitive areas. Tacrolimus demonstrated a more effective clinical outcome compared with calcitriol.
Liao
Y H
YH
Department of Dermatology, National Taiwan University Hospital, College of Medicine, National Taiwan University, 7, Chung-Shan South Road, Taipei 100, Taiwan.
Chiu
H C
HC
Tseng
Y S
YS
Tsai
T F
TF
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D002117:Calcitriol / Q000008:administration & dosage / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D005148:Facial Dermatoses / Q000188:drug therapy; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014815:Vitamins / Q000627:therapeutic use*
D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; D009824:Ointments; D014815:Vitamins; D002117:Calcitriol; D016559:Tacrolimus