Comparison of the efficacy of Tacrolimus 0.1 ointment and Tacrolimus 0.1 plus topical pseudocatalase/superoxide dismutase gel in children with limited vitiligo: a randomized controlled trial

摘要

Background: The pathogenesis of vitiligo is complex and multifactorial, accumulating evidence of increased oxidative stress and reduction in catalase levels in vitiligo patients has been shown, hence, pseudocatalase/superoxide dismutase (PSD) gel has been used as treatment option for vitiligo. Aim: To assesses the synergic effect of PSD when combines with Tacrolimus 0.1 ointment versus Tacrolimus 0.1 alone. Method: A randomized controlled trial that included 49 children with vitiligo with limited area (10 or less). Patients were randomized into two groups: Group 1 (24 patients) were treated only with Tacrolimus 0.1 ointment whereas Group 2 (25 patients) were treated with Tacrolimus 0.1 ointment plus PSD. Degree of repigmentation compared to baseline was assessed at 3, 6, and 9 months. Results: The median age was 10.05 years (range 2-18). The percentages of pigmentation on 3, 6, and 9 months for Group 1 were 23.9, 40.4, and 60, respectively and for Group 2 were 23.2, 40.7, and 62.4, respectively. There was no significant difference according to repigmentation percentages between the two groups (p > .86, p > .97, and p > .78, respectively). Conclusions: The results showed that the addition of PSD to Tacrolimus ointment in children with limited vitiligo was not associated with any therapeutic benefit.