Transdermal radiofrequency (V ERASER®) plus polidocanol sclerotherapy versus polidocanol sclerotherapy alone for the treatment of reticular veins and telangiectasias. A randomized controlled trial (TYPER trial)

Abstract

Background

Sclerotherapy with polidocanol is the gold standard treatment for telangiectasias and varicose veins, but technologies such as transdermal radiofrequency are also available. Transdermal radiofrequency (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 between transdermal radiofrequency and sclerotherapy for treating telangiectasias and reticular veins. Forty-one patients were randomized to either transdermal radiofrequency plus polidocanol sclerotherapy or polidocanol sclerotherapy alone and underwent a single treatment session. Efficacy was assessed using vessel clearance analysis in pre- and post-treatment images and the Aberdeen Varicose Vein Questionnaire.

Results

Forty-six patients were enrolled. Both treatments significantly reduced vessel length in a single session (p < .001). Sclerotherapy showed an average reduction of 30.7%, while transdermal radiofrequency reduced it by 33%, with no statistically significant difference (p = .596). Quality of life improved, with pain reduction in 40% and 55% of patients in the right and left lower limbs, respectively (p = .030 and p = .002).

Conclusion

Transdermal radiofrequency was not superior to standard of care polidocanol sclerotherapy. Both methods improved quality of life, particularly in reducing pain associated with varicose veins.

Keywords

venous disease transdermal radiofrequency telangiectasia reticular veins

Capsule summary

• Chronic venous disease is a chronic condition and therapeutic options are limited.

• We tested a transdermal radiofrequency device plus sclerotherapy with polidocanol versus sclerotherapy with polidocanol alone. There was a trend for improvement for both treatment groups. Transdermal radiofrequency may be effective in adults with chronic venous disease.

Introduction

Chronic venous disease (CVD) is a progressive and multifactorial condition characterized by dysfunction of the venous system, which can lead to symptoms such as edema, a sensation of heaviness in the legs, pain, and skin changes. It also leads to visible clinical manifestations such as telangiectasias and varicose veins. The etiology of CVD involves anatomical and functional factors that result in chronic venous hypertension, frequently associated with valvular incompetence, alterations in the venous wall, and blood reflux.¹ The primary risk factors for developing CVD include advancing age, female sex, family history, obesity, pregnancy, smoking, and professional activities that require prolonged periods of standing.^2,3

Reticular veins and telangiectasias are subdermal, superficial, and dilated veins that appear as reddish, greenish, or bluish lesions in CVD. Their appearance is a common complaint affecting more than 80% of the population.⁴

Currently, sclerotherapy is the gold-standard treatment for reticular veins and telangiectasias, and the most used sclerosing agent for treating these vessels is polidocanol. However, the use of transdermal laser and radiofrequency is increasingly being studied, and characteristics have been identified that make these techniques more versatile, allowing the treatment of larger-caliber vessels without surgical intervention.⁵

Radiofrequency can be defined as non-ionizing radiation generated by an alternating or pulsed electron current that forms electromagnetic waves. When these electromagnetic waves encounter tissues, they promote atomic vibration, producing thermal energy and heating the target tissue. Thermogenic stimulation primarily affects proteins and promotes the remodeling of collagen in the vein walls, resulting in their denaturation. This thermal injury causes endothelial denudation and edema of the vessel wall elements, leading to fibrosis through an inflammatory process.⁶

The primary objective of this study was to evaluate the efficacy and safety of a new device, the V Eraser®, which combines liquid sclerotherapy and thermocoagulation using radiofrequency in comparison to standard-of-care polidocanol sclerotherapy for the treatment of telangiectasias and reticular veins.

Methods

Study design and oversight

TYPER was a prospective, randomized, multicenter (2 centers) and comparative clinical study evaluating transdermal thermal radiofrequency plus sclerotherapy with polidocanol versus sclerotherapy alone with polidocanol, single session for the treatment of reticular veins and telangiectasias.

The study was approved by the Institutional Review Board (IRB) number 5.416.679 and the National Research Ethics Commission of the Ministry of Health under the Certificate of Presentation for Ethical Consideration (CAAE) number 58014021.7.0000.5485. The trial was registered at clinicaltrials.gov (NCT NCT06962813).

The first and senior authors designed the trial. The first draft of the manuscript was written by the first author and revised based on comments from all the authors. No writing assistance was provided. The participants signed and received a copy of the Informed Consent Form before any study procedure.

The REDCap™ electronic tool was used to securely collect and store data, ensuring the confidentiality of sensitive information and enabling the randomization of patients into either the sclerotherapy or the V Eraser treatment group. Inclusion criteria were patients willing to sign informed consent ranging 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 were patients with great saphenous or small saphenous vein insufficiency, with allergies to polidocanol or with contraindications to treat varicose veins.

Study procedures

All patients were registered in the REDCap™ software and assessed for Chronic Venous Disease (CVD) symptoms, including tingling, pain, burning, heaviness, and pruritus. The Venous Clinical Severity Score (VCSS) and the Aberdeen Varicose Vein Questionnaire (AVVQ) were also applied.

Patients were randomly assigned to one of two groups using the REDCap™ system: Group 1: Liquid sclerotherapy with polidocanol 0.25% (telangiectasias) or 0.5% (reticular veins) treatment group. Group 2: Transdermal radiofrequency treatment group, in which sclerotherapy with polidocanol was performed simultaneously with radiofrequency emission at the needle tip. The concentration of polidocanol was maintained at 0.25% for telangiectasias and 0.5% for reticular veins.

All selected patients had Doppler evaluation of the lower limbs, as one of the exclusion criteria was insufficiency of the great or small saphenous veins.

In both groups, sclerotherapy for vessels classified as telangiectasias was performed using liquid polidocanol at a concentration of 0.25%, administered with a 3 mL syringe and a 30G ½ needle. On the other hand, reticular veins were treated with liquid polidocanol at a concentration of 0.5%, using a 5 mL syringe and a 27G ½ needle.

For the randomized group treated with the radiofrequency device, where sclerotherapy was combined with transdermal radiofrequency, the sclerotherapy protocol followed the same standardized approach described above for telangiectasias and reticular veins.

The energy parameters selected on the device were 36% for telangiectasias and 40% for reticular veins. These parameters were determined based on previous reports on the literature, ensuring procedure safety since no official technical recommendation exists for energy levels specific to vessel size.^6,7

Transdermal Radiofrequency can be performed in two ways: In one approach, sclerotherapy is first performed, followed by thermocoagulation using micro-needles with a thickness of 0.075 mm. This needle is positioned perpendicularly over the target vein, through the skin, without an additional puncture. The objective is to induce spasms in the vein that has already undergone chemical injury, enhancing the treatment outcome. The second technique consists of the simultaneous execution of sclerotherapy and thermal ablation. This technique was applied to the current study using the V Eraser® device (V Company, Brazil).⁷

The tested tool is a radiofrequency device with an ablative technique for treating telangiectasias and reticular veins. This device consists of a platform that enables energy transmission to the needle tip through a thermal element connected to the needle (Figure 1). The correct use of the device consists of the following steps: (1) Ensuring the patient is comfortably positioned in the treatment environment, with the target vessels visible. (2) Placing the neutral plate in contact with the patient’s skin in a dry, muscular area, avoiding contact with metallic structures. (3) Selecting the sclerosing agent, attaching the syringe to the device’s holder, and connecting the needle to the thermal element. (4) Adjusting the power settings as required. (5) Performing antisepsis of the skin.

Figure 1.

V Eraser® platform (figure from the instruction manual adapted by the author).

After these steps, the target vessel was punctured, ensuring that the needle was inserted as much as possible into the vessel’s lumen, occupying a significant portion of its length. Once the puncture was performed and the needle was positioned correctly, the sclerotherapy began simultaneously with the operator pressing the syringe plunger, activating the device’s foot pedal, and continuously withdrawing the needle from the skin. This coordinated action of sclerotherapy, radiofrequency activation, and needle withdrawal continued until the needle was entirely removed from the treated vessel.

The needle withdrawal movement is crucial to prevent excessive energy accumulation at a single point, which could cause pain and local burns. Activating the foot pedal while the needle is outside the vessel and too close to the puncture site may result in superficial burns. The same protocol was followed for treating subsequent vessels, with energy adjustments as needed.

A single treatment was performed for both arms, and an outcomes evaluation was performed on day 30, when the patient was photographed.

All treated areas were photographed using an iPhone® 12 smartphone ensuring standardized imaging with strict lighting control (two 36 cm LED rings, 30 watts, 3500K). Measurement analysis before and after the procedure was performed through the ImageJ® software. (Figure 2). The Siberian® skin cooler was used to protect and reduce pain during the procedures. The VenoLight® phleboscope was utilized to identify feeder veins connected to telangiectasias.

Figure 2.

Measurement analysis before and after the procedure for the primary outcome using ImageJ® software.

After both treatments, dressings were applied. For telangiectasia puncture sites, small cotton balls and microporous tape were applied. For reticular veins, cotton rolls No. 2 and microporous tape covering the treated vessel.

Patients were instructed to remove the dressings in the morning after the procedure and were not advised to wear compression stockings or any other compressive devices.

Patients were re-evaluated 30 days after the procedure, during which post-procedure photographs were taken for primary outcome analysis. The Aberdeen Varicose Vein Questionnaire (AVVQ) was administered, and any side effects were assessed. Complications and patient’s complaints such as stains, pain, burns, and edema were observed clinically by the primary investigator on day 30 after the procedures.

Outcomes

Primary efficacy outcome

Image analysis of photos 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 (Figure 3).⁸

Figure 3.

CONSORT diagram.

Co-primary efficacy outcome

The Aberdeen Varicose Vein Questionnaire (AVVQ) applied on day 30.⁹

Primary safety outcome

Safety evaluation was performed by checking patients’ complaints and clinical assessment of complications such as stains, pain, burns, and edema.

Statistical analysis

The analysis was performed by the Statistical Package for the Social Sciences (SPSS 25.0)®. Intergroup data were subjected to the Wilcoxon test, while intragroup data were analyzed using the Mann-Whitney test and Student’s t-test. The AVVQ quality of life questionnaire was analyzed using McNemar’s test. The number of patients was determined based on a convenience sample.

Results

Between February and April 2023, 46 patients were enrolled from the Venous Disease Outpatient Clinic at Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo, Brazil.

The baseline characteristics of the studied population are presented in Table 1.¹⁰ No significant differences were observed between the groups. The CONSORT diagram is depicted in Figure 3.

Table 1.

Baseline characteristics.

Variables	V Eraser + sclerotherapy with polidocanol (N = 20)	Sclerotherapy with polidocanol (N = 20)	P-value
Female sex No. (%)	17 (85)	19 (95)	0.61
Age, median (years)	52 (32-74)	53 (34-67)	0.47
BMI, mean (kg/m3) (SD)	27.5 (4.67)	29.1 (5.53)	0.34
Systemic arterial hypertension, No. (%)	4 (20)	7(35)	0.70
Diabetes, No. (%)	3 (15)	2 (10)	0.64
Smoking, No. (%)	4 (20)	2 (10)	0.67
C1, No.(%)	6 (30)	5 (25)	1.00
C2, No.(%)	12 (60)	12 (60)	1.00
C3, No.(%)	1 (5)	3 (15)	0.61
C4, No.(%)	0	0
C5, No.(%)	1 (5)	0	1.00
Symptoms
Tingling, No. (%)	7 (35)	10 (50)	0.53
Heaviness, No. (%)	14 (70)	14 (70)	1.00
Burning sensation, No. (%)	9 (45)	8 (40)	0.77
Itching, No. (%)	7 (35)	12 (60)	0.18

Both groups had significant reduction in the length of the treated vessels. The mean length of residual veins was 28 cm in sclerotherapy with thermal radiofrequency plus polidocanol group and 25.9 cm in polidocanol alone group (p < .01).

Sclerotherapy with polidocanol plus radiofrequency was not significantly more effective than polidocanol alone in eliminating reticular veins and telangiectasia from the treatment area (33% vs 30.7%; p = .596), Figure 4.

Figure 4.

Primary outcome results.

For the Aberdeen Varicose Vein Questionnaire (AVVQ), the only question that showed a statistically significant improvement in symptoms was question 2: “In the past 2 weeks, how many days did your varicose veins cause you pain?”. For this question, 40% of patients (p = .030) reported reduced symptoms for the lower right limb, and 55% of patients (p = .002) for the lower left limb. Responses for the remaining questions remained consistent in both pre-and post-treatment questionnaires. This analysis was not stratified by treatment type.

Side effects identified with 30 days post-procedure included 65% hyperpigmentation included both groups (polidocanol n = 13, radiofrequency plus polidocanol n = 13) and 15% crust formation in the transdermal radiofrequency group. No other adverse events were reported. Table 2 depicts all summarized results.

Table 2.

Primary, co-primary and safety outcomes results.

Variables	Thermal radiofrequency + sclerotherapy with polidocanol (N = 20)	Sclerotherapy with polidocanol alone (N = 20)	P-value
Primary efficacy outcome
Length of residual veins on ImageJ analysis	28 cm	25.9 cm	<0.001
Eliminating reticular veins and telangiectasia	33%	30.7%	0.596
Co-primary efficacy outcome
Aberdeen varicose vein questionnaire (AVVQ)Question 2 - reducing symptoms	40%*	55%**	* 0.030** 0.002
Safety outcomes
Hyperpigmentation	65%	65%	-
Crust	15%	0	-

Discussion

Both polidocanol sclerotherapy and the radiofrequency device effectively reduced the length of reticular veins and telangiectasias, with an average reduction of 30.7% and 33%, respectively. Although the radiofrequency showed a slight increase in efficacy, the difference between the methods in the parameters used in this study was not statistically significant (p = .596), supporting previous studies that demonstrate equivalence between techniques for treating reticular veins.⁶

The optimization of therapeutic parameters, based on clinical experience and literature, contributed to the safety and efficacy of both treatments, with no severe complications reported.

Treating reticular veins and telangiectasias in the lower limbs can often present a challenge due to hemodynamic complexity and anatomical correlations between the superficial and deep venous systems. Additionally, achieving a satisfactory outcome that meets patient expectations with safe, effective, and minimally invasive outpatient procedures remains a challenge.

In the latest Brazilian Guideline on Chronic Venous Disease, published by the Brazilian Society of Angiology and Vascular Surgery, transdermal radiofrequency treatment for CEAP C1 patients is classified as recommendation IIa, level of evidence C, highlighting the need for further data to support its use. This classification indicates that randomized trials are still required, although expert opinion remains favorable for its application.¹¹

Although sclerotherapy with sclerosant agents remains the gold standard and holds a level A recommendation, no ideal sclerosant agent has yet been identified. Consequently, new technologies have been developed to enhance efficacy and safety, reducing local adverse effects such as hyperpigmentation, matting, and small ulcers. LASER devices can be used with glucose sclerotherapy¹² and with different polidocanol concentrations.¹³ A study involving 111 CEAP C1 patients compared sclerotherapy alone versus sclerotherapy combined with low-energy radiofrequency and concluded that low-energy thermocoagulation resulted in a higher clearance rate, fewer complications, less pain, and a lower incidence of pigmentation.⁷

Regarding side effects, the incidence of hyperpigmentation (65%) and crust formation (15%) was consistent with literature reports, which describe these effects as common and self-limited in similar treatments. These high rates of pigmentation were observed in the evaluated population and might have occurred due to the brevity of the 30-day follow-up visit. The presence of crusts was identified in 3 patients in the group that used the transdermal radiofrequency and was a transitory adverse event.¹⁴

A statistically significant improvement was observed in varicose vein-related pain, particularly in response to the question: “In the past 2 weeks, for how many days did your varicose veins cause you pain?”. Reported pain decreased in 40% and 55% of patients for the right and left lower limbs, respectively (p = .030 and p = .002). This improvement aligns with previous studies demonstrating a direct relationship between vein diameter reduction and symptom relief. Although other questionnaire items did not reach statistical significance, the stability in responses regarding the absence of ulcers and the need for analgesics reinforces clinical stability after treatment.¹⁵

Finally, in his pilot study including 40 patients there were no statistically significant differences between treatment groups. Since there are no previous studies evaluating the clinical relevance of the transdermal radiofrequency device used, there is a need for complementation. We believe this work is pioneering and serves as a reference for future studies. A possible increase in sample size, along with a longer follow-up time, more treatment sessions, and a higher power, may lead to a different efficacy outcome than the one observed in the current paper.

Although it was not the objective of the study, a visual improvement in the size reduction of varicose veins was observed, which should be considered for future studies. This pattern was also not analyzed, and it is possible to develop new studies to evaluate this observed data. The cost-effectiveness was also not investigated and should be considered for future studies.

Conclusion

No differences in efficacy were observed comparing transdermal radiofrequency associated with polidocanol sclerotherapy using the radiofrequency device versus polidocanol sclerotherapy alone for the treatment of reticular veins and telangiectasias. Both therapies improved quality of life.

Footnotes

Acknowledgements

The authors would like to thank Science Valley Research Institute for the logistical support for this academic study. A special thank you to Professor Erika Fukunaga, who performed all the statistical analysis.

ORCID iDs

Rebeca Higino Becker

Caroline Cândida Carvalho de Oliveira

Rafaela Palermo Marcondes

Ariadne Ribeiro Negrão

Flávia Magella

Giuliano Giova Volpiani

Samantha Neves

Renata Camila Barros Rodrigues

Mariana Ferreira Borges Firmo Rodrigues

Viviane Santana da Silva

Camilla Moreira Ribeiro

Rodrigo Kikuchi

Eduardo Ramacciotti

Consent for publication

The authors obtained consent for the publication of anonymized data and included it at the time of article submission to the journal, stating that all patients gave consent with the understanding that this information may be publicly available. No recognizable photographs or other identifiable material are disclosed in the current article.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This was a self-funded study with a modest support from Science Valley Research Institute that supported employees (VSS, co-author) that helped with the REDCap® data collection and logistics for study procedures.

Declaration of conflicting interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ER reports grants and consulting fees from Bayer and Pfizer, the Brazilian Ministry of Science and Technology, and personal fees from Aché Pharma, Novartis, Althia, EMS and Daiichi-Sankyo outside the submitted work. No disclosures were reported for the current study of the other co-authors.

Trial registration

Identifier: NCT06962813

Guarantor

The guarantor is Eduardo Ramacciotti, MD, Ph D, who is the senior author of the paper. Dr Ramacciotti holds important global publications, is a professor of Health Sciences at Santa Casa School of Medicine and professor of Thrombosis and Hemostasis at Loyola University Medical Center, Maywood, IL, USA. The current paper is a master thesis (MPH) of the principal author (RHB) under the formal mentorship of Dr Ramacciotti.

IRB approval status

Reviewed and approved by Irmandade da Santa Casa de Misericórdia de São Paulo IRB; approval number CAAE: 58014021.7.0000.5485. The study was registered at Clinicaltrials.gov: NCT06962813

Contributorship

RHB, ER, GGV, RK, SN, RAC, CMR and FRS conceived the trial and wrote the initial proposal. All other authors contributed intellectually relevant content. ER and CMR estimated the sample size and drafted the statistical analysis. RHB, FMSMO, VSS, ARN, RPM actively enrolled patients for the trial, RHB performed all the treatments. RK, SN, FRS, RPM, RCBR, FMSMO, CCCO and MFBFR performed the imaging exams. RK, FRS and FMSMO participated on the core laboratory. ER checked the performed statistical analysis, that was carried out by EF (acknowledgments). The initial draft of the manuscript was written by ER, RHB, RAC, SN, FRS and RK who had full access to and verified all the data underlying the study. All authors had access to the data, contributed to the manuscript, agreed to submit for publication, and vouch for the integrity, accuracy, and completeness of the data and for the fidelity of the trial to the protocol.

Reprint requests

Eduardo Ramacciotti

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