Clinical trial NCT06962813: Transdermal Radiofrequency V ERASER Versus Polidocanol Sclerotherapy for Reticular Veins and Telangiectasias
Official title: Transdermal Radiofrequency (V ERASER) Versus Polidocanol Sclerotherapy for the Treatment of Reticular Veins and Telangiectasias: A Randomized Controlled Trial (TYPER Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins Leg
Telangiectasias
Keywords: radiofrequency
sclerotherapy
varicose veins
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm parallel study
Primary purpose: TREATMENT

Brief summary: This study tested V Eraser, Transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs

Detailed description: Chronic Venous Disease causes symptoms such as pain, edema, and skin manifestations, including telangiectasias and varicose veins. Sclerotherapy with polidocanol is the gold standard treatment; however, technologies such as laser devices and transdermal radiofrequency are also available. The V Eraser, a device that combines transdermal radiofrequency and sclerotherapy, was developed to treat these conditions.

Methods: This was a prospective, randomized, and comparative study comparing V Eraser with sclerotherapy for the treatment of telangiectasias and reticular veins. Forty-one patients were randomized to either V Eraser or polidocanol sclerotherapy and underwent a single treatment session. Efficacy was assessed using the Aberdeen Varicose Vein Questionnaire and vessel clearance analysis in pre- and post-treatment images.

Eligibility criteria: Inclusion Criteria:

* Patients willing to sign informed consent
* Patients from 18 to 80 years old with CVD classified as CEAP clinical classes C1 to C5, but only telangiectasias and reticular veins not connected to larger varicosities

Exclusion Criteria:

* Patients with great saphenous or small saphenous vein insufficiency.
* Patients with allergies to polidocanol
* Patients with contraindications to treat varicose veins

Primary outcomes:
measure: Photographic analysis
timeFrame: 30 days
measure: Aberdeen AVVQ questionnaire
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo
state: SP
Study officials:
affiliation: Faculty of Medical Sciences of Santa Casa de São Paulo
name: Rebeca Higino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Siribumrungwong B, Noorit P, Reanpang T, Pornwaragorn C, Wilasrusmee C, Wongsuwanich S, Srikuea K, Orrapin S, Benyakorn T, Garratt AM, Rerkaserm K. Reliability, validity, and minimal clinically important differences for the Thai-version of the Aberdeen Varicose Vein Questionnaire (AVVQ-Thai) in patients with chronic venous disease. F1000Res. 2024 Oct 11;13:486. doi: 10.12688/f1000research.147716.2. eCollection 2024.
citation: Diken AI, Alemdaroglu U, Ozyalcin S, Hafez I, Tunel HA, Yalcinkaya A, Ecevit AN. Adjuvant radiofrequency thermocoagulation improves the outcome of liquid sclerotherapy in the treatment of spider veins of the leg: A pilot study. Phlebology. 2021 Sep;36(8):620-626. doi: 10.1177/02683555211006534. Epub 2021 Apr 4.
citation: Key DJ. A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming. J Drugs Dermatol. 2015 Nov;14(11):1272-8.
citation: Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2023 Mar;11(2):231-261.e6. doi: 10.1016/j.jvsv.2022.09.004. Epub 2022 Oct 12.