The efficacy of pimecrolimus 1% cream plus narrow-band ultraviolet B in the treatment of vitiligo: a double-blind, placebo-controlled clinical trial.
BACKGROUND
Recently, narrow-band ultraviolet B (NB-UVB) and topical immunomodulators have been successfully used in the treatment of vitiligo.


OBJECTIVE
To determine whether the combination of pimecrolimus with NB-UVB accelerates the response time and/or improves the degree of response in patients with vitiligo.


METHODS
Sixty-eight patients with vitiligo enrolled in this randomized, double-blind, placebo-controlled study. The patients were randomized into two groups and treated with NB-UVB plus either pimecrolimus or placebo for 3 months. Tri-weekly radiation was started at 280 mJ/cm(2), with 15% increments for each subsequent treatment until erythema was reported or a maximum of 800 mJ/cm was achieved. At baseline and 6 and 12 weeks after commencement of therapy, vitiliginous patches were measured.


RESULTS
Fifty patients completed the 3-month study. No significant side effects except self-limited erythema and pruritus were observed. After 12 weeks of treatment, repigmentation of the facial lesions was higher in patients treated with combined pimecrolimus and NB-UVB compared with the placebo plus NB-UVB group (64.3 vs 25.1%) (p < 0.05%). There was no statistically significant difference in the repigmentation rate between the two groups on other body areas.


CONCLUSIONS
On the face, NB-UVB works better if combined with pimecrolimus 1% cream rather than used alone.
Esfandiarpour
Iraj
I
Kerman Medical University, Department of Dermatology, Kerman, Iran. iraiesfandyar@yahoo.ca
Ekhlasi
Ali
A
Farajzadeh
Saeedeh
S
Shamsadini
Saadollah
S
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D018709:Statistics, Nonparametric; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014467:Ultraviolet Therapy / Q000379:methods*; D014820:Vitiligo / Q000175:diagnosis* / Q000628:therapy*; D055815:Young Adult
D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus