A double-blind, randomized trial of 0.05% betamethasone vs. topical catalase/dismutase superoxide in vitiligo

Abstract

Background: Among all the topical immunomodulators, vitiligo's mainstay therapy includes topical corticosteroids. Many other non-immune theories have also been suggested for vitiligo's pathogenesis, but the role of oxidative stress has gained more importance in recent years.

Objective: To compare the effect of topical 0.05% betamethasone vs. catalase/dismutase superoxide (C/DSO).

Study design: Randomized, matched-paired, double-blind trial.

Setting: Dermatology Section, University of Antioquia, Medellín, Colombia.

Subjects: Patients (aged > 18 years or between 12 and 18 years) with parent's informed consent, with stable or active bilateral vitiligo.

Intervention: Topical 0.05% betamethasone or C/DSO.

Methods: Two lesions similar to each other in size were chosen. All assessments were made by two blinded investigators, and photographs were subjected to morphometry analysis.

Main outcome: Skin repigmentation by digital morphometry.

Results: Twenty-five patients were enrolled in the study (21 women and 4 men). Mean age of participants was 40 years (range: 12-74 years). One patient on C/DSO experienced a mild local erythematous papular rash that self-resolved. At 4 months of therapy, there was no statistical difference on the percentage of repigmentation between betamethasone and C/DSO (5.63% +/- 27.9 vs. 3.22% +/- 25.8, respectively, P = 0.758). After 10 months of therapy, the percentage of skin repigmentation increased to 18.5 +/- 93.14% with betamethasone and to 12.4 +/- 59% with C/DSO, but again, we found no statistical differences (P = 0.79).

Discussion and conclusions: Few studies have described objective methods to evaluate repigmentation among vitiligo patients. Digital morphometry provides an objective assessment of repigmentation in vitiligo. Objective vitiligo repigmentation with topical C/DSO at 10 months is similar to topical 0.05% betamethasone. Although a mild adverse effect was related to the use of C/DSO, such finding was not severe enough to discontinue treatment.