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 © July 2011
Joshua M. Berlin MD,a David P. Eisenberg MD,b Mindy B. Berlin RN,a Robert A. Sarro MD,a Douglas R. Leeman PA-C MPH,a Howard Fein MDc
aDermatology Associates, PA, of the Palm Beaches, Boynton Beach, FL bUniversity of Connecticut Health Center, Farmington, CT cPalos Verdes Dermatology Associates, Inc., Palos Verdes, CA
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.
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
