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A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of a High-Potency Topical Corticosteroid After Sclerotherapy for Reticular and Telangiectatic Veins of the Lower Extremities

Friedmann, Daniel P. MD, FAAD*,†; Liolios, Ana M. MD, FAAD; Wu, Douglas C. MD, PhD, FAAD; Goldman, Mitchel P. MD, FAAD, FACPh†,‡; Eimpunth, Sasima MD†,§

doi: 10.1097/DSS.0000000000000467
Original Article
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BACKGROUND Although typically mild, transient, and expected, most adverse events (AEs) postsclerotherapy are inflammatory in nature.

OBJECTIVE To evaluate the effects of a high-potency topical corticosteroid (TC) applied immediately postsclerotherapy.

MATERIALS AND METHODS Subjects undergoing bilateral lower extremity sclerotherapy with polidocanol had extremities randomized to a single application of betamethasone dipropionate and placebo saline solutions immediately post-treatment in a double-blind manner. Adverse events were assessed for each extremity by subjects at t = 0 (preapplication) and t = 15 (15 minutes postapplication) and by an investigator at t = 0 and t = 15, and at Days 14 and 60. Subjects and investigator evaluated efficacy with a quartile improvement scale.

RESULTS Sixteen female subjects completed the study. Subjects reported no statistically significant differences in AEs between TC and placebo at either t = 0 or t = 15. Investigator scores for erythema and swelling/urtication were not significantly different between groups at the same time points. Although most subjects demonstrated 26% to 75% improvement at Day 60, results were not significantly different between extremities on subject and investigator evaluation.

CONCLUSION High-potency TC application immediately postsclerotherapy produced no statistically significant differences in subject- and investigator-assessed AEs and clearance rates compared with placebo. Foam sclerotherapy with polidocanol is safe and effective for the treatment of lower extremity reticular veins.

*Westlake Dermatology Clinical Research Center, Westlake Dermatology & Cosmetic Surgery, Austin, Texas;

Cosmetic Laser Dermatology, San Diego, California;

Department of Dermatology, University of California, San Diego, San Diego, California;

§Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Address correspondence and reprint requests to: Daniel P. Friedmann, MD, FAAD, Westlake Dermatology Clinical Research Center, 8825 Bee Cave Rd, Ste 100, Austin, TX 78746, or e-mail: daniel@westlakedermatology.com

D. P. Friedmann and M. P. Goldman are consultants for and have received research support from Merz Aesthetics, Inc. Compression stockings for this study were provided at no cost by Medi USA (Whitsett, NC).

Work was performed at Cosmetic Laser Dermatology, San Diego, CA.

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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