ClinicalTrials.gg
CompletedNCT06962813TYPERUpdated May 8, 2025

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

An interventional study of Radiofrequency V Eraser in Varicose Veins Leg and Telangiectasias, sponsored by Science Valley Research Institute. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Science Valley Research Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Varicose Veins Leg
  • Telangiectasias

Keywords

  • radiofrequency
  • sclerotherapy
  • varicose veins
03

In context

Telangiectasis

69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.

This study's enrollment of 46 is above the median of 30 across 59 interventional studies indexed under Telangiectasis.

Browse Telangiectasis studies →

Lead sponsor

Science Valley Research Institute is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients willing to sign
  • 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

Exclusion Criteria:

  • Patients with great saphenous or small saphenous vein insufficiency.
  • Patients with allergies to polidocanol
  • Patients with to treat varicose veins
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Radiofrequency V Eraser

    radiofrequency

    Procedure: Radiofrequency V Eraser

  • Active comparator
    Polidocanol sclerotherapy

    Standard of care, varicose veins, sclerotherapy

    Procedure: Radiofrequency V Eraser

Interventions

  • ProcedureRadiofrequency V Eraser

    standar of care sclerotherapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

  2. Aberdeen AVVQ questionnaire

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

    Time frame: 30 days

07

Study locations

1 site
  • Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo
    São Paulo, SP 02276-140, Brazil
08

References and documents

Publications

  • 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. PubMed 30707327 ↗
  • 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. PubMed 39925999 ↗
  • 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. PubMed 33813962 ↗
  • Key DJ. A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming. J Drugs Dermatol. 2015 Nov;14(11):1272-8. PubMed 26580877 ↗
  • 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. Erratum In: J Vasc Surg Venous Lymphat Disord. 2024 Mar;12(2):101719. doi: 10.1016/j.jvsv.2023.101719. PubMed 36326210 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06962813
Lead sponsor
Science Valley Research Institute
Responsible party
Eduardo Ramacciotti (Senior investigator, Science Valley Research Institute) — Principal investigator
First posted
May 8, 2025
Start date
Jan 10, 2023
Primary completion
Jan 2, 2025
Completion
Apr 10, 2025
Last update
May 8, 2025

Study contacts

Rebeca Higino, MD
principal investigator · Faculty of Medical Sciences of Santa Casa de São Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion