Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T).

Abstract

OBJECTIVE:

The aim of this study was to compare the effectiveness and safety of two sclerosing agents used to treat telangiectasias in the lower limbs: 0.2% polidocanol + 70% hypertonic glucose (HG) vs. 75% HG alone.

METHODS:

A prospective, randomised, triple blind, controlled, parallel group trial with patients randomly assigned in a 1:1 ratio between January and December 2015, with a two month follow up, from a single academic medical centre in Brazil, was carried out. Participants were women aged 18-65 years with telangiectasias on the lateral aspect of one thigh, classified as C1EpAsPn who underwent sclerotherapy in a single session with 0.2% polidocanol + 70% HG or 75% HG alone to treat the telangiectasias on an area limited by a rectangular template. The primary effectiveness endpoint was elimination of 75% of the telangiectasias within 60 days vs. the pre-treatment pattern. The length of vessels was measured on images obtained before and after treatment using ImageJ software. Safety outcomes were analysed immediately, 7 days, and 60 days after the treatment, and included pigmentation.

RESULTS:

A total of 115 patients were included, 98 of whom completed the study. Sclerotherapy with 0.2% polidocanol + 70% HG was significantly more effective than with 75% HG alone to treat telangiectasias in the target area (82.2% vs. 63.9%; p < .001); considering a minimum improvement of 75%, there was a 0.49 risk reduction (95% confidence interval 0.24-0.98; p = .047). No severe adverse events occurred in either group. Pigmentation was the most common minor adverse event and was significantly shorter in length in the group treated with 0.2% polidocanol + 70% HG (median 0 cm vs. 0.5 cm, respectively; p = .033).

CONCLUSION:

Polidocanol 0.2% plus 70% HG had better results than 75% HG alone in sclerosing telangiectasias. No severe adverse events occurred. Pigmentation occurred in both groups and was shorter in length in the group treated with 0.2% polidocanol + 70% HG.

• Authors: Matheus Bertanha, Winston B Yoshida, Paula A Bueno de Camargo, Regina Moura, Dênia Reis de Paula, Carlos R Padovani, Marcone L Sobreira
• Journal: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery (Eur J Vasc Endovasc Surg) Vol. 61 Issue 1 Pg. 128-135 (Jan 2021) ISSN: 1532-2165 [Electronic] England
• PMID: 32778489 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

Chemical References

• Sclerosing Solutions
• Polidocanol
• Glucose

Topics

• Adolescent
• Adult
• Aged
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Glucose (administration & dosage, therapeutic use)
• Humans
• Middle Aged
• Polidocanol (administration & dosage, therapeutic use)
• Sclerosing Solutions (administration & dosage, therapeutic use)
• Sclerotherapy (methods)
• Telangiectasis (drug therapy)
• Thigh (blood supply)
• Young Adult