Transdermal Radiofrequency V ERASER Versus Polidocanol Sclerotherapy for Reticular Veins and Telangiectasias

NCT06962813 | Completed

• 1 other identifier: TYPER TRIAL
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Varicose Veins Leg; Telangiectasias

Keywords

radiofrequency; sclerotherapy; varicose veins

Outcome Measures

Primary Outcomes (2)

• Photographic analysis

  Image analysis of photos was performed on day 30. Using the ImageJ software, two blinded evaluators analyzed the pre- and post-procedure photographs, measuring the vessel lengths in both images

  30 days

• Aberdeen AVVQ questionnaire

  The Aberdeen Varicose Vein Questionnaire (AVVQ) was applied on day 30

  30 days

Study Arms (2)

Radiofrequency V Eraser

EXPERIMENTAL

radiofrequency

Procedure: Radiofrequency V Eraser

Polidocanol sclerotherapy

ACTIVE COMPARATOR

Standard of care, varicose veins, sclerotherapy

Procedure: Radiofrequency V Eraser

Interventions

Radiofrequency V Eraser PROCEDURE

standar of care sclerotherapy

Polidocanol sclerotherapy; Radiofrequency V Eraser

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Science Valley Research Institute: lead

Study Sites (1)

Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 02276-140, Brazil

Location

Related Publications (5)

• 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.

  PMID: 30707327 BACKGROUND

• 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.

  PMID: 39925999 BACKGROUND

• 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.

  PMID: 33813962 BACKGROUND

• Key DJ. A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming. J Drugs Dermatol. 2015 Nov;14(11):1272-8.

  PMID: 26580877 BACKGROUND

• 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.

  PMID: 36326210 BACKGROUND

MeSH Terms

Conditions

Telangiectasis; Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rebeca Higino, MD

  Faculty of Medical Sciences of Santa Casa de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior investigator

Model Details: 2 arm parallel study

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: January 10, 2023
• Primary Completion: January 2, 2025
• Study Completion: April 10, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)