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

Abstract

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.

Keywords:

• Vitiligo
• Tacrolimus 0.1%
• pseudocatalase/superoxide dismutase (PSD)
• catalase

Acknowledgments

The study was approved and supported by the deanship of research in Jordan University of Science & Technology. We would like to thank ACM Laboratoire Jordan and Pella Pharmaceuticals co. Ltd for their generosity in supplying the patients with pseudocatalase/superoxide dismutase gel and Tacrolimus 0.1% ointment.

Disclosure statement

The authors declare no conflict of interest in relation to this study.

Data availability

Data used in the article is available on request from the corresponding author.

Additional information

Funding

The study was supported by a research grant from deanship of research at Jordan University of Science and Technology [grant number: 10/114/2018].