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Surgery versus Lauromacrogol 400 injection for superficial labial venous malformations in children and adults: a randomized controlled trial

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

A rare condition called superficial labial venous malformation causes abnormal, soft blood vessels to appear on the lip, which can affect appearance and mouth function. The study compares the usual surgical removal of these vessels with an injection of a medication called polidocanol (brand name Aetoxisclerol), which contains the substance lauromacrogol 400. The injection is given directly into the lesion to make the abnormal vessels shrink.

The purpose of the study is to determine whether surgery or the injection provides better overall results, including reduction in size of the lesion, scar quality, and lip symmetry, after one year.

Participants are randomly assigned to either the surgical group or the injection group and are followed for 12 months. After the chosen procedure, follow‑up visits occur at regular intervals to take photographs, complete questionnaires, and record any pain using a rating system called the visual analog scale, where 0 means no pain and 10 means the worst pain. An imaging test known as MRI is used to measure the size of the lesion, and blood samples are taken to check clotting factors such as D-dimer and fibrinogen. Pain diaries and satisfaction surveys are also collected throughout the study period.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Join the study and give consent

    After agreeing to participate, you will be asked to sign a consent form that explains the purpose of the trial and what will be required of you.

  2. Step 2

    Baseline assessments

    Before any treatment, photographs of the lip will be taken, an mri scan will be performed, and you will complete questionnaires that measure aesthetic discomfort, mouth function, drooling, and speech clarity.

    The same information will be collected from a parent if you are younger than six years old.

  3. Step 3

    Randomization to treatment group

    You will be randomly assigned to one of two groups: surgery or sclerotherapy. the assignment is made by the study staff and you will not know which group you will be placed in until the procedure day.

  4. Step 4

    Procedure day

    If you are assigned to the surgery group, a surgeon will perform an operation to remove the venous malformation on your lip.

    If you are assigned to the sclerotherapy group, a doctor will inject aetoxisclerol 3% directly into the lesion. the injection consists of 4 ml of the solution, which is the amount specified for the study.

  5. Step 5

    Immediate post‑procedure monitoring

    After the procedure you will stay in the clinic for a short observation period during which staff will check for any immediate side effects or complications.

    You will be given a diary to record any painful days and the intensity of pain (using a scale from 0 to 10) for the month before the procedure, the month after the procedure, and the month before the 12‑month visit.

  6. Step 6

    Discharge and home care

    Once the observation period is completed and you are stable, you will be allowed to go home.

    You will receive written instructions on how to care for the treated area and how to complete the pain diary.

  7. Step 7

    First follow‑up visit (month 1)

    Approximately one month after the procedure you will return for a follow‑up visit.

    The staff will review your pain diary, assess any adverse effects, and ask you to rate your acceptance of the treatment on a visual analog scale (vas).

  8. Step 8

    Second follow‑up visit (month 3)

    Three months after the procedure you will have another visit.

    The same assessments as at month 1 will be repeated, including pain diary review, safety check, and treatment‑acceptance rating.

  9. Step 9

    Final assessment (month 12)

    Twelve months after the procedure you will attend the final study visit.

    Photographs of the lip will be taken again, an mri scan will be performed, and you will complete the same set of questionnaires that were used at baseline.

    The overall effectiveness of the treatment will be evaluated based on lesion size reduction, scar quality, and lip symmetry using a likert scale, and your overall satisfaction will be recorded.

Who can join the trial?

7 criteria

  • Age: You must be at least 4 years old.
  • You must have a superficial labial venous malformation, which is a small vein abnormality on the lip that causes symptoms.
  • The affected area (called a venous pocket) must be between 10 mm² and 50 mm² in size (about the size of a small pencil eraser).
  • You cannot have had any surgery or a special imaging‑guided procedure on that lip area in the past two years.
  • The condition must be reachable for both sclerotherapy (a treatment that injects medicine to shrink the vein) and surgery.
  • You must be enrolled in a Social Security system (your health insurance or national health coverage).
  • You need to sign an informed written consent form, either yourself if you are an adult or by a parent or legal guardian if you are a child.

Who cannot join the trial?

8 criteria

  • Pregnant or breastfeeding women – cannot join because the study could affect the baby.
  • Women of childbearing age without effective contraception – cannot join if they are not using reliable birth control throughout the study.
  • Patients under legal guardianship, curatorship, or other legal protection – cannot join because a legal guardian must give consent.
  • Other vascular abnormalities – cannot join if they have other blood‑vessel problems besides the lip condition.
  • Contraindications to MRI – cannot join if they cannot safely have an MRI scan, which is a type of imaging that uses magnets and radio waves to look inside the body.
  • Contraindication to Aetoxisclerol® – cannot join if they cannot receive this medication used in sclerotherapy because of a medical reason.
  • Contraindication to general anesthesia – cannot join if they cannot safely be put completely asleep and pain‑free during surgery.
  • Contraindication to surgery – cannot join if they cannot safely have an operation because of a medical reason.
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Investigated drugs

AETOXISCLEROL is a liquid medicine that is injected directly into the abnormal veins on the lip. It contains a substance called polidocanol, which makes the walls of the tiny veins shrink and scar over. This helps the veins close up, reducing the size of the lesion and improving the appearance of the lip.

Surgery is a medical procedure where a surgeon cuts away or removes the abnormal vein tissue from the lip. In this trial, surgery is compared with the injection medicine to see which method works better for shrinking the lesion, making a good scar, and keeping the lips looking symmetrical.

What is already known about the treatment

AETOXISCLEROL 3% (60 mg/2 mL), solution injectable - This medication is supplied as a clear liquid that is given by injection into the vein. It is an approved sclerosing agent (polidocanol) that has been used for many years to treat abnormal superficial veins and is listed in medical literature under ATC code C05BB02. The main use in this trial is to shrink superficial labial venous malformations, a rare condition affecting the lip. It works by gently irritating the lining of the small blood vessels, causing them to close and be reabsorbed by the body, and it belongs to the class of vascular sclerosing drugs.

Investigated diseases

Superficial labial venous malformation - Superficial labial venous malformation is a congenital vascular anomaly consisting of dilated veins located just beneath the surface of the lip. The lesions are usually present at birth or become noticeable in early childhood and appear as soft, bluish or purple patches that may enlarge over time. As the malformation grows, it can cause visible swelling of the lip and may become more prominent with activities that increase blood flow, such as crying or exertion. The condition tends to progress slowly, with gradual increase in size or thickness of the affected area. In some cases, the venous channels can become more tortuous, leading to a raised or nodular appearance. The malformation does not typically resolve on its own.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521374-34-00Protocol codeDR240317Estimated enrolment50 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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