title: 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.
authors.affiliation: Department of Dermatology, University Hospital Center of Nice, Nice, France.
authors.forename: Marine
authors.initials: M
authors.lastname: Cavalié
authors.affiliation: Department of Dermatology, University Hospital Center of Bordeaux, Bordeaux, France.
authors.forename: Khaled
authors.initials: K
authors.lastname: Ezzedine
authors.affiliation: Department of Clinical Research and Innovation, University Hospital Center of Nice, Nice, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Fontas
authors.affiliation: Department of Dermatology, University Hospital Center of Nice, Nice, France.
authors.forename: Henri
authors.initials: H
authors.lastname: Montaudié
authors.affiliation: Department of Dermatology, University Hospital Center of Nice, Nice, France.
authors.forename: Emeline
authors.initials: E
authors.lastname: Castela
authors.affiliation: Department of Dermatology, University Hospital Center of Nice, Nice, France; Centre de Recherche Clinique (CRC), University Hospital of Nice, Nice, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bahadoran
authors.affiliation: Department of Dermatology, University Hospital Center of Bordeaux, Bordeaux, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Taïeb
authors.affiliation: Department of Dermatology, University Hospital Center of Nice, Nice, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Lacour
authors.affiliation: Department of Dermatology, University Hospital Center of Nice, Nice, France; C3M, INSERM U1065, team 12, Nice, France. Electronic address: passeron@unice.fr.
authors.forename: Thierry
authors.initials: T
authors.lastname: Passeron
mesh_terms: D000287:Administration, Topical; D000328:Adult; D065095:Calcineurin Inhibitors / Q000627:therapeutic use; D016000:Cluster Analysis; D003879:Dermatologic Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010858:Pigmentation; D011788:Quality of Life; D012008:Recurrence; D012867:Skin / Q000187:drug effects; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome; D014820:Vitiligo / Q000188:drug therapy* / Q000523:psychology
chemical_list: D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; D016559:Tacrolimus