학술논문

A double-blind, randomized trial of 0.05% betamethasone vs. topical catalase/dismutase superoxide in vitiligo
Document Type
Report
Source
Journal of the European Academy of Dermatology and Venereology. Nov, 2008, Vol. 22 Issue 11, p1359, 6 p.
Subject
Clinical trials -- Analysis
Corticosteroids -- Analysis
Vitiligo -- Analysis
Superoxide -- Analysis
Language
English
ISSN
0926-9959
Abstract
To purchase or authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1468-3083.2008.02839.x Byline: G Sanclemente (*[dagger][double dagger]), JJ Garcia ([double dagger]), JJ Zuleta (s.), C Diehl ([paragraph]), C Correa ([double dagger]), R Falabella (**) Keywords: betamethasone; catalase/dismutase superoxide; RCT; vitiligo Abstract: 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, Medellin, 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% [+ or -] 27.9 vs. 3.22% [+ or -] 25.8, respectively, P = 0.758). After 10 months of therapy, the percentage of skin repigmentation increased to 18.5 [+ or -] 93.14% with betamethasone and to 12.4 [+ or -] 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. Author Affiliation: ([dagger])Department of Internal Medicine, School of Medicine, GRID-Dermatology Section, University of Antioquia, Medellin, Colombia ([double dagger])Phototherapy Unit, IPS Universitaria, Universidad de Antioquia, Medellin, Colombia (s.)Escuela de Investigacion Medica Aplicada, School of Medicine, Universidad de Antioquia, Medellin, Colombia ([paragraph])Department of Dermatology, Universidad Nacional de Cordoba, Cordoba, Argentina (**)Dermatology Section, Department of Internal Medicine, School of Medicine, Universidad del Valle Article History: DOI: 10.1111/j.1468-3083.2008.02839.x Received: 4 November 2007, accepted 6 May 2008 Article note: (*) Corresponding author, Department of Internal Medicine, School of Medicine, GRID-Dermatology Section, University of Antioquia, Carrera 51 A # 62-42, Phototherapy Unit, Medellin 001, Colombia, tel. +57 4326 9214; fax +574353 6964; E-mail: gsanclemente@une.net.co