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.

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 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 ( > .86,  > .97, and  > .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.