Narrowband (NB) ultraviolet B (UV-B) phototherapy has been shown to effectively decrease the spread of active vitiligo, but the use of atorvastatin does not appear to add any benefit to NB UV-B treatment for repigmentation or the halting of disease progression, according to the results of an interventional, randomized, single-blind trial (ClinicalTrials.gov identifier: NCT02432534) published in JAMA Dermatology.
The current trial was conducted from May 2015 to February 2017. In this study, active vitiligo was defined as “new patches or extension of old lesions in the past 3 months and the presence of hypochromic borders and/or confetti-like depigmentation under a Wood lamp examination.”
Centralized block randomization, stratified by center, was assigned in a 1:1 ratio to either group A: atorvastatin 40 mg/day for 1 month followed by 80 mg/day for 5 months, plus NB-UV-B phototherapy 2 times per week for 6 months; or group B: NB-UV-B phototherapy 2 times per week for 6 months.
Clinical examination, blood tests, and photography were performed at baseline and at 1, 3, and 6 months. The primary study end point was the percentage of decrease in Vitiligo Area Scoring Index at 6 months. Secondary end points included the Vitiligo European Task Force Vitiligo Extent Score (extent, 0%-100%; stage, 0-20; and disease progression, −5 to 5, all representing lowest to highest) and the Dermatology Life Quality Index (0 [lowest] to 30 [highest]).
A total of 30 patients were randomly assigned to treatment. Median patient age was 45 years (range, 27-63 years) in the NB-UV-B plus atorvastatin group and 38 years (range, 30-51 years) in the NB-UV-B group. Of the 30 participants, 16 were of European ancestry and 14 were Asian. Of the 30 randomized patients, 29 completed the study and were included in the modified intent-to-treat analysis.
The mean Vitiligo Area Scoring Index score between baseline and month 6 for group A was −2.95 (range, −5.81 to −0.09; P =.04), and for group B it was −4.38 (range, −7.35 to −1.42; P =.005), with the difference in mean Vitiligo Area Scoring Index changes between the 2 groups not statistically significant (P =.49).
The Vitiligo European Task Force spreading score at month 6 was –3.31 (range, −4.73 to −1.89: P <.001) in group A and −3.41 (range, −4.89 to −1.94; P <.001) in group B. The difference in the mean Vitiligo European Task Force spreading changes between the 2 groups was not statistically significant (P =.92).
Overall, 10 patients in group A experienced adverse events, which included diarrhea, abdominal pain, myalgia, and headache. One patient developed transient elevation of muscle enzyme levels that normalized once the atorvastatin dose was reduced to 40 mg. No adverse events were reported in group B.
The investigators concluded that NB UV-B phototherapy can effectively reduce the spread of active vitiligo; however, atorvastatin did not add any benefit to NB UV-B treatment. More specific therapies designed to target the pathways involved in vitiligo may offer better results.
Nguyen S, Chuah SY, Fontas E, et al. Atorvastatin in combination with narrowband UV-B in adult patients with active vitiligo: a randomized clinical trial [published online April 4, 2018]. JAMA Dermatol. doi: 10.1001/jamadermatol.2017.6401