Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T): Protocol for a randomized, controlled clinical trial.
BACKGROUND
Telangiectasias are defined as small venules abnormally dilated, located in the intradermal portion of the skin, of reddish or bluish tinge, their diameter not exceeding 1 mm; they are classified by the American Venous Forum as mild venous disease CEAP C1. Conventional treatment consists of chemical sclerotherapy, considered a minimally invasive technique with rapid clinical recovery. A wide variety of sclerosing solutions can be used for this purpose.


METHODS
This project intends to include 96 patients that will be randomized to a triple-blind study. Inclusion criteria are women between 18 and 65 years, with telangiectasia on the lateral thigh. Male patients, female patients with chronic venous disease CEAP 2 to 6, women with allergies, pregnant, breastfeeding, with any type of skin problems or any decompensated clinical disease will be excluded. All patients included will be submitted to venous ultrasound mapping in order to rule out venous disease not clinically visible, deep venous system insufficiency, and insufficiency of the ostial valve of the great saphenous vein. One group will be treated with glucose 75% solution and the other will receive polidocanol 0.2% diluted in glucose 70%. Each patient will receive only 1 treatment session in 1 single member. The volume of sclerosing solution will not exceed 5 mL and the treatment area will be limited to a region of 150 cm on the lateral thigh. Clinical follow-up will be: 1 initial visit, when the clinical report will be filled; photographic record and treatment with sclerotherapy (D0); follow-up visits after 7 and 60 days (D7 and D60, respectively), always with clinical and photographic documentation.


CONCLUSIONS
The project intends to evaluate the efficacy and safety of sclerotherapy in eliminating telangiectasia in a predetermined area in order to establish efficacy and safety parameters for the treatments presented.


CONCLUSIONS
This protocol for clinical trial will provide date to determine the efficacy and safety of sclerotherapy with the solutions presented.
ClinicalTrial.gov NCT02657252 Date: 01/12/2016 (retrospectively registered).
aDiscipline of Angiology and Vascular of Departament of Surgery and Orthopedics, Botucatu Medical School, UNESP bBotucatu Medical School, UNESP, Botucatu, São Paulo, Brazil.
Matheus
M
Bertanha
Paula Angeleli Bueno de
PA
Camargo
Regina
R
Moura
Winston Bonetti
WB
Yoshida
Rafael Elias Farres
RE
Pimenta
Jamil Victor de Oliveira
JV
Mariúba
Giovana Piteri
GP
Alcantara
Dênia Reis
DR
de Paula
Marcone Lima
ML
Sobreira
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D005947:Glucose / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012107:Research Design; D012597:Sclerosing Solutions / Q000627:therapeutic use*; D015911:Sclerotherapy / Q000379:methods*; D013684:Telangiectasis / Q000628:therapy*; D013848:Thigh; D055815:Young Adult
D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols; D005947:Glucose
J Vasc Surg. 2004 Dec;40(6):1248-52
15622385
Dermatol Surg. 2010 Jun;36 Suppl 2:1010-25
20590708
Dermatol Surg. 2010 Jun;36 Suppl 2:1026-33
20590709
Dermatol Surg. 2004 May;30(5):687-93; discussion 693
15099309
J Cosmet Laser Ther. 2012 Oct;14(5):239-42
23016533
Dermatol Surg. 2012 Aug;38(8):1322-30
22620717
Int Angiol. 2013 Jun;32(3):261-5
23711678
Vasa. 1995;24(4):313-8
8533439
N Engl J Med. 2008 Apr 3;358(14 ):1525-6
18385510
J Am Acad Dermatol. 1996 Mar;34(3):523-8
8609276
Dermatol Surg. 2002 Feb;28(2):153-5
11860427
Trials. 2014 Dec 19;15:497
25527165
Arch Surg. 1974 Dec;109(6):793-6
4608096
Dermatol Surg. 1999 May;25(5):381-5; discussion 385-6
10469077
Dermatol Surg. 2002 Oct;28(10):969; author reply 969-70
12410688
Phlebology. 2014 Jul;29(6):338-54
23559590
Dermatol Surg. 2004 Mar;30(3):367-72; discussion 372
15008862
J Am Acad Dermatol. 1987 Aug;17(2 Pt 1):167-82
3305603
Dermatol Surg. 2006 Dec;32(12):1444-52
17199651