Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtained for Leg Sclerotherapy
Version of Record online: 23 MAY 2011
© 2011 by the American Society for Dermatologic Surgery, Inc.
Volume 37, Issue 6, pages 812–815, June 2011
How to Cite
WEISS, R. A., VOIGTS, R. and HOWELL, D. J. (2011), Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtained for Leg Sclerotherapy. Dermatologic Surgery, 37: 812–815. doi: 10.1111/j.1524-4725.2011.01906..x
- Issue online: 23 MAY 2011
- Version of Record online: 23 MAY 2011
BACKGROUND In the arena of venous sclerotherapy, sodium tetradecyl sulfate (STS), hypertonic saline, and polidocanol (POL) are the most widely used agents in the world for treating endothelial vein wall destruction. Pharmaceutical-grade STS and hypertonic saline are available from manufacturers. Until 2010, POL was only available in the United States through compounding pharmacies.
OBJECTIVE To identify whether a risk exists when using freely available compounded POL samples for venous sclerotherapy.
MATERIALS AND METHODS Six samples of 1% POL solutions obtained from four compounding pharmacies were evaluated using gas chromatography mass spectrometry (GC/MS) assays for POL concentration and identification of material impurities.
RESULTS Disparities in POL concentrations between six samples ranged from 1.0% to 3.1%. The GC/MS analysis showed impurities in all six compounded POL samples.
CONCLUSIONS In this study, compounded POL solutions did not deliver the claimed concentration five out of six times. This inconsistency poses risks to the patient and the treating physician during venous sclerotherapy with pharmacy-compounded POL.
Merz Aesthetics provided funding for this study. Dr. Weiss is a consultant to Merz. Mr. Voigts is employed by Merz Aesthetics (San Mateo, CA). Dr. Howell is a freelance medical writer.