Tacrolimus, UVB therapy synergistic duo

May 1, 2005

Nice, France — Results of a comparative, prospective, randomized study undertaken by French dermatologists indicate that topical tacrolimus ointment 0.1 percent (Protopic, Fujisawa) plus phototherapy with a 308-nm excimer laser can be a highly effective combination for the treatment of recalcitrant, localized vitiligo.

However, the response to the dual regimen varies depending on anatomic location of the lesions, and long-term safety of the approach remains an important, unresolved issue, says Thierry Passeron, M.D., investigator and lead author of the recently published study (Arch Dermatol. 2004 Sep;140(9):1065-1069).

The trial The trial enrolled 14 patients (ages 12 to 63 years) who had vitiligo for at least three months and at least two pairs of symmetrical, vitiliginous lesions, each measuring ≥4 cm2. In each patient, target lesions were randomized to semi-weekly treatment for up to 24 sessions with the excimer laser (TALOS, WaveLight Laser Technology AG2) alone or combined with twice daily application of tacrolimus ointment. Contralaterally-located lesions were left untreated and served as controls.

Needs more study "Vitiligo treatments available to date often provide unsatisfactory results. Recent data point to the 308-nm excimer laser and tacrolimus ointment as two new potentially useful therapeutic options for achieving repigmentation in localized vitiligo, and we undertook this trial to investigate the hypothesis that they may work synergistically," explains Dr. Passeron, department of dermatology, Hopital de L'Archet, here.

"Consistent with the results of another recently published study, our investigation confirmed the efficacy of the excimer laser for treating vitiligo at sites that are typically UV-responsive and demonstrated the ability to achieve significantly better repigmentation by combining it with topical tacrolimus. However, there is a need to consider the potential for long-term side effects using this multimodal approach. Therefore, we believe this combination should be considered mainly for UV-sensitive areas and cautiously pending further study."

The 14 patients ranged in age from 12 to 63 years and were predominantly female (86 percent). Two were Fitzpatrick skin type II, three were Fitzpatrick skin type III and one was Fitzpatrick skin type IV. Previous therapies, including narrowband UVB phototherapy in some patients, had been tried and mostly failed in all but one study subject.

A total of 23 lesions were randomized to treatment with the combination approach and 20 to excimer laser treatment alone. All patients completed the study, with three patients stopping treatment after 15 to 16 sessions due to complete repigmentation.

At the end of the 12 weeks, repigmentation was observed in all 23 lesions treated with the combination approach compared with 17 (85 percent) of 20 lesions receiving excimer laser treatment only. Untreated control lesions showed no evidence of spontaneous repigmentation.

The mean number of laser treatment sessions needed to achieve onset of repigmentation was 10 for the dual therapy group versus 12 for the excimer laser monotherapy group. Repigmentation of ≥75 percent was achieved by 16 (70 percent) of the dual-treated lesions compared with only four (20 percent) of those receiving localized phototherapy only, and the difference compared with control was statistically significant only for the dual treatment.

Prognostic factors The data were also analyzed to identify potential predictors of response. Patient age, gender, skin type and minimal erythema dose (MED) were not significantly associated with outcome, but anatomic location of the lesions was important.