Maintenance Therapy of Adult Vitiligo with 0.1% Tacrolimus Ointment: A Randomized, Double Blind, Placebo–Controlled Study

Abstract

The risk of relapse after successful repigmentation in vitiligo is estimated to 40% within the first year. It has been shown in atopic dermatitis that continuous low-level use of topical corticosteroids and calcineurin inhibitors in previously affected skin can prevent new flares. We hypothesized that a twice-weekly application of 0.1% tacrolimus ointment might be effective for maintaining repigmentation in therapeutically repigmented lesions of vitiligo patients. After randomization, sixteen patients with 31 patches were assigned to the placebo group and 19 patients with 41 patches were assigned to the tacrolimus group. In the intention-to-treat analysis, 48.4% of lesions showed depigmentation in the placebo group, whereas 26.8% did in the tacrolimus group (P=0.059). The intention-to-treat results did not remain significant after adjustment for within-patient clustering, odds ratio (OR) 2.55; 95% confidence interval (CI; 0.65-9.97); P=0.1765. The per-protocol analysis (n=56) showed that 40% of lesions had some depigmentation in the placebo group, whereas only 9.7% did in the tacrolimus group (P=0.0075). The per-protocol results remained significant after adjustment for within-patient clustering: OR 6.22; 95% CI (1.48-26.12); P=0.0299. Our study shows that twice-weekly application of 0.1% tacrolimus ointment is effective in preventing the depigmentation of vitiligo patches that have been previously successfully repigmented.

Vitiligo as a skin memory disease: The need for early intervention with immunomodulating agents and a maintenance therapy to target resident memory T cells

“…Therefore, a maintenance therapy remains important to consider in vitiligo management to prevent new episodes of flare‐up as well as accumulation of T RM cells. In this line, it has been clearly demonstrated that the use of topical calcineurin inhibitors as a maintenance therapy twice a week, in patients with repigmented lesions, can reduce the recurrences of previously repigmented vitiligo lesions . These results are consistent with the potential role of the maintenance therapy to dampen the local activation/proliferation of skin resident T RM important for flare‐up of the disease.…”

Topical Histamine Stimulates Repigmentation of Nonsegmental Vitiligo by a Receptor-Dependent Mechanism

“…It is worth noting that only 1 out of 15 patients in the present study relapsed during an 8-month follow-up period, while the 1-year relapse rate after treatment is over 30% in other studies [44], mandating that maintenance therapy may be required to sustain the improvements of repigmentation [45]. Moreover, no serious adverse reactions were observed in the present study.…”

The efficacy and safety of tacrolimus as mono‐ and adjunctive therapy for vitiligo: A systematic review of randomised clinical trials

“…Manual searching found one further article. Of these 19 RCTs matched the selection criteria . Reasons for excluding 58 papers are detailed in Supplementary Fig.…”

“…Five studies were not eligible for meta‐analysis owing to lack of homogeneity. The study from Cavalié et al .…”

“…A case‐specific protocol that weighs the risks and advantages of using mono‐ or adjuvant therapy is, therefore, recommended, and it can be adapted depending on the clinical course of the lesions. Maintenance is also a vital aspect of the treatment plan and should be considered and followed up, especially with the high rate of relapse in vitiligo that was estimated to be 40% in the first year . Cavalié et al .…”