A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of a Citrus Bioflavanoid Blend in the Treatment of Senile Purpura

July 2011 | Volume 10 | Issue 7 | Original Article | 718 | Copyright © 2011

Abstract

Background: Senile purpura is a common, chronic skin condition affecting more than 10 percent of individuals over the age of 50. Despite being a benign condition, the continual development of purpura lesions in afflicted patients is frequently a source of significant visual and social concern. To date, there are no known effective treatments for this condition.
Objectives: To evaluate the efficacy of a novel nutraceutical citrus bioflavonoid blend in improving the skin's appearance in patients with senile purpura.
Methods: A six-week, randomized, multicenter, placebo-controlled, double-blind study was conducted to determine whether a uniquely formulated, oral citrus bioflavonoid supplement could treat active lesions of senile purpura while preventing new lesions from arising. Seventy patients with senile purpura were enrolled and 67 completed the study. Subjects were randomized into two groups receiving either a citrus bioflavonoid blend or placebo medication, which was taken orally twice daily for six weeks. Clinical evaluations were performed by blinded investigators at two locations.
Results: A statistically significant reduction in the number of new purpura lesions in the skin area undergoing clinical study was documented. At the end of six weeks, the citrus bioflavonoid blend treated group showed a 50 percent reduction in purpura lesions from baseline. Patient self-assessment of the effectiveness of the medication echoed the results of an investigator global assessment with a statistically significant improvement in the skin's appearance noted by the patients receiving the active medication. No adverse effects were noted by either the patients or investigators.
Conclusion: This new treatment appears to both safely and effectively diminish skin bruising in patients with senile purpura.

J Drugs Dermatol.2011;10(7):718-722.

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INTRODUCTION

Senile or actinic purpura was originally described by Bateman in 1817.1 In his original treatise, the morphology of purpura was described as dark purple blotches of an irregular form and various magnitude. Although this original description still remains true, a treatment for this problem has remained elusive for nearly two centuries. It has been estimated that up to 11.9 percent of people over the age of 50 are afflicted with senile purpura.2 The condition appears to be more prevalent with increasing age as a recent study found senile purpura in 29.3 percent of elderly patients examined in a longterm care facility.3 Despite the fact that there are no long-term health sequelae associated with senile purpura (SP), the lesions are often cosmetically disturbing to patients as they tend to occur in visible areas of the body, such as the extensor surfaces of the forearms, legs and hands. The goal of this study was to determine the effects of a novel citrus bioflavonoid blend (CBB) as a potential treatment for SP

METHODS

Study Design

This multi-center, randomized, double-blind vehicle-controlled study was designed to evaluate the efficacy and safety of a proprietary CBB relative to a placebo in the treatment of SP when administered daily for six weeks. The study was approved by the institutional review board of Concordia Clinical Research. Thirty-two male and thirty-eight female participants

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