Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias

Summary

This prospective, randomized, controlled, intraindividual split-leg clinical trial will compare isolated polidocanol foam sclerotherapy with the Cryo-Laser After Foam (CLaF) technique for the treatment of reticular veins and telangiectasias of the lower limbs. The study will include 70 women aged 18 to 60 years with bilateral CEAP C1 telangiectasias and/or reticular veins. Each participant will receive CLaF in one lower limb and isolated foam sclerotherapy in the contralateral limb, with treatment laterality determined by randomization. The CLaF technique consists of polidocanol foam sclerotherapy followed immediately by transdermal 1064-nm Nd:YAG laser under continuous cold-air cooling. The study will evaluate vascular clearance, residual vascular area, hyperpigmentation, retained thrombi and need for drainage, pain, adverse events, aesthetic improvement, patient satisfaction, and quality of life during follow-up through 180 days.

Timeline

Start

2026-09-01

Primary completion

2027-02

Completion

2027-05

Publications

• Background Ribeiro-Samora GA, Carvalho MLV, de Moura RMF, Pereira DAG. Limitations of VEINES QOL/SYM for discriminating chronic venous insufficiency severity. J Vasc Bras. 2019 Nov 29;19:e20180096. doi: 10.1590/1677-5449.180096.
• Background Moreno-Moraga J, Pascu ML, Alcolea JM, Smarandache A, Royo J, David F, Trelles MA. Effects of 1064-nm Nd:YAG long-pulse laser on polidocanol microfoam injected for varicose vein treatment: a controlled observational study of 404 legs, after 5-year-long treatment. Lasers Med Sci. 2019 Sep;34(7):1325-1332. doi: 10.1007/s10103-019-02736-1. Epub 2019 Feb 1.
• Background Moreno-Moraga J, Hernandez E, Royo J, Alcolea J, Isarria MJ, Pascu ML, Smarandache A, Trelles M. Optimal and safe treatment of spider leg veins measuring less than 1.5 mm on skin type IV patients, using repeated low-fluence Nd:YAG laser pulses after polidocanol injection. Lasers Med Sci. 2013 May;28(3):925-33. doi: 10.1007/s10103-012-1180-6. Epub 2012 Aug 11.
• Background Moreno-Moraga J, Smarandache A, Pascu ML, Royo J, Trelles MA. 1064 nm Nd:YAG long pulse laser after polidocanol microfoam injection dramatically improves the result of leg vein treatment: a randomized controlled trial on 517 legs with a three-year follow-up. Phlebology. 2014 Dec;29(10):658-66. doi: 10.1177/0268355513502786. Epub 2013 Aug 29.
• Background Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60.
• Background Nakano LC, Cacione DG, Baptista-Silva JC, Flumignan RL. Treatment for telangiectasias and reticular veins. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD012723. doi: 10.1002/14651858.CD012723.pub2.
• Background Fonseca MM, Mocelin FJ, Poltronieri LR, Guimaraes Filho JL. Treatment of varicose veins using the Cryo laser after foam technique. J Vasc Surg Cases Innov Tech. 2024 May 29;10(4):101549. doi: 10.1016/j.jvscit.2024.101549. eCollection 2024 Aug.
• Background Bertanha M, Yoshida WB, Bueno de Camargo PA, Moura R, Reis de Paula D, Padovani CR, Sobreira ML. Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T). Eur J Vasc Endovasc Surg. 2021 Jan;61(1):128-135. doi: 10.1016/j.ejvs.2020.07.007. Epub 2020 Aug 7.
• Background Bertanha M, Jaldin RG, Moura R, Pimenta REF, Mariuba JVO, Lucio Filho CEP, Alcantara GP, Padovani CR, Yoshida WB, Sobreira ML. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial. JAMA Dermatol. 2017 Dec 1;153(12):1249-1255. doi: 10.1001/jamadermatol.2017.3426.

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Indications