title: Treatment of vitiligo with narrowband-UVB (TL01) combined with tacrolimus ointment (0.1%) vs. placebo ointment, a randomized right/left double-blind comparative study.
abstract: BACKGROUND
  Only a few, small double-blind clinical trials have been reported for the treatment of vitiligo. Narrowband-ultraviolet B (NB-UVB) is an established form of treatment for this condition. Tacrolimus ointment is assumed to have an effect in some patients.
  
  
  OBJECTIVE
  To assess the additive effect of tacrolimus ointment (0.1%) once daily in vitiligo patients treated with NB-UVB.
  
  
  METHODS
  In a randomized double-blind trial, patients with stable symmetrical vitiligo were treated half-side with tacrolimus ointment (0.1%) and half-side with placebo ointment. Whole body NB-UVB was given twice or thrice weekly for at least 3 months. As a morphometric device, Visitrak(TM) was used to measure the area of the vitiligo target lesions.
  
  
  RESULTS
  Of 40 patients, 27 had a better effect on the tacrolimus side. The degree of improvement was significantly better on the tacrolimus side (P = 0.005). The median reduction in the target lesion areas was 42.1% on the tacrolimus side and 29% on the placebo side. There was a correlation between the effect and the number of topical tacrolimus applications (P = 0.044), but there was no correlation with the number of UV treatments given; neither any significance of gender, age, skin type, duration of disease, familial occurrence of vitiligo nor presence of other autoimmune disease or atopy was observed. We found a significant reduction in the patients' subjective disease impact during the treatment period (P < 0.001).
  
  
  CONCLUSIONS
  According to this study, the combination of NB-UVB and tacrolimus ointment (0.1%) is more effective than UV treatment alone in patients with vitiligo. The effect is tacrolimus total dose-dependent.
authors.affiliation: Department of Dermatology, Oslo University Hospital, Oslo, Norway. eli.johanne.nordal@oslo-universitetssykehus.no
authors.forename: E J
authors.initials: EJ
authors.lastname: Nordal
authors.forename: G E
authors.initials: GE
authors.lastname: Guleng
authors.forename: J R
authors.initials: JR
authors.lastname: Rönnevig
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010919:Placebos; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D014466:Ultraviolet Rays; D014820:Vitiligo / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D010919:Placebos; D016559:Tacrolimus