Surgery Versus Intra-lesional Sclerosis With Polidocanol (Aetoxisclerol) in Labial Venous Malformations in Children and Adults (SASOV)

November 10, 2026 updated by: University Hospital, Tours

Surgery Versus Intra-lesional Sclerosis With Polidocanol (Aetoxisclerol) in Labial Venous Malformations in Children and Adults: a Randomized Controlled Trial

The goal of this clinical trial is to learn if Surgery works better than Intra-lesional Sclerosis With Polidocanol to treat Labial Venous Malformations in Children and Adults. It will also learn about the safety of both approaches. The main questions it aims to answer are:

  • Does Surgery has greater Global efficacy, including (including lesion volume reduction, scar quality, and lip symmetry) than Intra-lesional Sclerosis With Polidocanol?
  • What complications do participants have when undergoing Surgery or Intra-lesional Sclerosis With Polidocanol? Researchers will compare surgery to Intra-lesional Sclerosis With Polidocanol.

Participants will be randomized to one of two treatment strategies:

  • Experimental group: Surgical excision of the labial venous malformation (VM).
  • Control group: Sclerotherapy strategy consisting of one or two sessions of intralesional polidocanol 3% injection.

Patients will be identified and recruited during multidisciplinary vascular anomalies clinics. The study protocol will be explained to eligible patients and their families. After obtaining written informed consent (or consent from both parents together with the child's assent, when applicable), participants will be enrolled in the study.

Following enrollment, participants will be randomly assigned to one of the two parallel treatment groups. A baseline assessment will be performed, and patients will receive a patient diary to record subjective outcomes, including pain, during the pre-intervention period until the date of the procedure.

Study follow-up visits will take place at 1 month (telemedicine visit), 3 months, and 12 months after treatment. Outcome assessments will be performed at each scheduled follow-up visit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France
      • Paris, France
        • Necker
        • Contact:
        • Principal Investigator:
          • Olivia BOCCARA, MD
      • Tours, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 4 years
  • Symptomatic venous malformation of the lower and/or upper lip
  • Venous pocket with an area of between 10 and 50 mm²
  • No history of surgery or interventional radiology in the area within the two years prior to inclusion
  • Suitable for sclerotherapy and surgery
  • Patient covered by the National Health Service
  • Informed, written consent from the child's legal guardians or from the participant themselves if they are of legal age

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Women of childbearing age not using effective contraception throughout the study
  • Patients under guardianship or curatorship, or subject to a court-ordered protective measure
  • Other vascular abnormalities
  • Contraindications to MRI
  • Contraindications to Aetoxisclerol®
  • Contraindications to general anaesthesia
  • Contraindications to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Surgical strategy

Experimental group: Surgical strategy for the excision of the superficial venous malformation (SVM). The surgery involves either partial reconstructive excision or complete excision of the SVM, depending on its size. The aim is to restore symmetry to the affected side of the lip in order to correct functional impairments and aesthetic effects.
Procedure: Excision by surgery of the superficial venous malformation

The surgery is performed under local or general anaesthesia (depending on the size of the SVM and the patient's age). Various coagulation devices (monopolar forceps with a Colorado tip, bipolar scissors, etc.) are used to section and dissect the SVM and to control haemostasis.
Active Comparator: Sclerotherapy strategy

Control group: Sclerotherapy strategy comprising one to two sessions of intra-lesional sclerotherapy with 3% polidocanol (Aetoxisclerol).
Drug: Sclerotherapy with Aetoxisclerol 3%

The procedure may be carried out under local or general anaesthesia, depending on the patient's age, anticipated tolerance and in accordance with standard practice at the centre. The patient is positioned in the supine position. Following manual and visual localisation of the target lesion, one or more needles of 30/100th to 18G gauge are inserted, and their position within the lesion is confirmed by gentle aspiration, which should yield blood without resistance. The injection of an iodinated contrast medium suitable for intravenous use, to characterise the drainage and under fluoroscopic guidance in the angiography suite, is recommended but not mandatory. Once in place, ≤ 2 mg/kg of polidocanol is injected per session, i.e. ≤ 0.067 mL/kg of 3% solution distributed amongst the needles (1/2 to 2 ampoules), until thrombosis occurs, significant tension is felt in the lesion, or pain develops.

Sclerotherapy may be repeated if necessary between 3 and 6 months after the first session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global change
Time Frame: From enrollment to Month 12 post intervention

Global change will be assessed 12 months after the intervention using a Likert scale ranging from -5 to +5 (0 = no improvement or worsening, higher scores mean better outcome), based on standardized pre- and post-intervention photographs. Assessments will be performed by an independent review panel comprising three physicians (one surgeon, one dermatologist, and one interventional radiologist) and one patient with a labial VM who did not participate in the study. The evaluation will be performed blinded to treatment allocation and will encompass changes in lesion volume, scar quality, and lip symmetry. A standardized photography protocol will be used. This primary endpoint (photograph-based assessment by an independent review panel) was selected to limit bias related to the open-label nature of the study, consistent with a PROBE design (Prospective Randomized Open, Blinded Endpoint).
From enrollment to Month 12 post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aesthetic impact of the venous malformation
Time Frame: Month 0 and Month 12

Assessment of aesthetic burden using a 0 to 10 visual analogue scale (VAS) with higher scores mean worse outcome, measured at baseline and 12 months after the intervention.
Month 0 and Month 12
Functional impact: overall mouth function
Time Frame: Month 0 and Month 12

Functional impact assessed using a 0 to 10 Visual Analogue Scale (VAS) for overall mouth function, with higher scores mean worse outcome
Month 0 and Month 12
Functional impact: lip continence
Time Frame: Month 0 and Month 12

Quantification of lip continence using a self-administered drooling questionnaire (Drooling Severity and Frequency Scale [DSFS]), score ranging from 2 to 9 with higher scores mean worse outcome
Month 0 and Month 12
Functional impact: speech intelligibility
Time Frame: Month 0 and Month 12

Speech intelligibility assessed using a self-administered questionnaire measuring speech-related intelligibility, the Intelligibility in Context Scale (ICS). Score ranging from 7 to 35, with higher scores mean better outcome
Month 0 and Month 12
Overall patient satisfaction: Likert scale
Time Frame: From enrollment to Month 12

Overall patient satisfaction assessed with a Likert scale ranging from -5 to +5 (0 = no improvement and no worsening), higher scores mean better outcome
From enrollment to Month 12
Overall patient satisfaction: Goal Attainment Scale
Time Frame: Month 12

Using achievement of personalized goals (maximum of three), predefined by the patient together with the investigator, assessed with the Goal Attainment Scale (GAS; scores ranging from -2 to +2, with higher scores mean better outcome). The Goal Attainment Scale (GAS) is a method for measuring treatment effectiveness by creating patient-specific outcome scales that are predefined before study participation. GAS aims to identify goals that are meaningful to the patient and related to their daily activities and individual priorities (Steinbook RM, 1977; DOI: 10.1001/archpsyc.1977.01770200061005).
Month 12
Number of painful days: Total number of painful days
Time Frame: The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post intervention visit (M12)

Total number of painful days assessed using either a patient diary or the online ePRO portal.
The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post intervention visit (M12)
Number of painful days: Number of painful days with a VAS pain score > 3/10
Time Frame: The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post-intervention visit (M12)

Number of painful days with a VAS pain score > 3/10 assessed using either a patient diary or the online ePRO portal.
The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post-intervention visit (M12)
Venous Malformation volume on MRI
Time Frame: Month 0 and Month 12

Venous malformation volume assessed before the intervention (within 6 months prior to treatment) and 12 months after the intervention (performed as part of routine care). Volumetric assessment will be conducted using a semi-automated thresholding method. Image analysis will be centralized and performed by an independent radiologist blinded to treatment allocation.
Month 0 and Month 12
Coagulation: D-dimer
Time Frame: Month 12

D-dimer
Month 12
Coagulation: fibrinogen level
Time Frame: Month 12

Fibrinogen level
Month 12
Adverse events including complications
Time Frame: From enrollment to Month 12

Safety including adverse events and complications, recorded using a patient diary or the online ePRO portal
From enrollment to Month 12
Acceptability of the interventions
Time Frame: Month 1, Month 3 , and Month 12

Acceptability of the interventions for the patient (or for parents in children aged < 6 years), assessed using a 0 to 10 Visual Analogue Scale (VAS), with higher scores mean worse outcome
Month 1, Month 3 , and Month 12
Healthcare costs
Time Frame: From enrollment to Month 12 following the intervention

In each arm, patients' healthcare utilization related to the procedure and outpatient care will be measured using hospital databases and a patient diary, then valued in euros from the perspective of the healthcare system.
From enrollment to Month 12 following the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR240317
  • 2025 (U.S. NIH Grant/Contract)
  • 2025-521374-34-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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