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

Not Applicable

Completed

• Conditions: Varicose Veins Leg; Telangiectasias

• Registration Number: NCT06962813
• Lead Sponsor: Science Valley Research Institute

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.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2025-01-02
• Status Verified: 2025-04
• Study Completion: 2025-04-10
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Photographic analysis	30 days	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
Aberdeen AVVQ questionnaire	30 days	The Aberdeen Varicose Vein Questionnaire (AVVQ) was applied on day 30

Trial Locations

Locations (1)

Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, SP, Brazil