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Verteporfin for Scar Prevention in Patients After Surgical Wounds

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

This study is being done in surgical wounds to see whether verteporfin can help prevent scar formation after surgery. The treatment will be given as an injection into the skin, and different doses of verteporfin will be compared with saline, which is also given by injection. The purpose of the study is to find the best dose and to see whether verteporfin may improve scar prevention.

People in the study will have either closed wounds, such as stitched cuts, or open wounds, such as small biopsy wounds made during the study. After treatment, the wounds will be followed over time while they heal, and the scars will be checked later. The study will also look at how safe the treatment is and whether any side effects occur, such as skin reactions or other body reactions. Some scars will also be looked at with medical pictures and ultrasound, which is a test that uses sound waves to create images inside the body.

Scar prevention is the main focus of this trial, and the study is designed to compare three verteporfin doses with saline in both open and closed wound types. The study will continue until the healing and scar checks are completed after treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment day

    After you join the study, you receive verteporfin or saline by injection into the skin. Saline is a salt-water solution used as a placebo, which means it does not contain the study medicine.

    The study uses three verteporfin dose levels: 0.5 mg/mL, 1.0 mg/mL, and 2.0 mg/mL. The source data also lists verteporfin 2.0 mg/mL and saline 2.0 mg/mL as the products used.

    The injections are given into open surgical wounds created by punch biopsy wounds and into closed surgical wounds that have been stitched. A punch biopsy is a small round skin wound made with a special tool.

    The purpose of this treatment step is to study scar prevention after surgery.

  2. Step 2

    Healing period after treatment

    After the injections, your wounds are followed as they heal.

    For the open wound part of the study, the time from the punch biopsy wound to complete skin healing is measured. This is called complete epithelialization, which means the skin surface has fully closed over the wound.

  3. Step 3

    3-month assessment

    At 3 months, your scars are checked.

    Scar quality is compared between the verteporfin dose groups and placebo using the Observer component of the Patient and Observer Scar Assessment Scale (POSAS). This is a scoring system used to rate how a scar looks and feels.

    For the closed wound part of the study, this assessment is done on the stitched incision segments.

    For the open wound part of the study, this assessment is done on the punch biopsy wounds.

  4. Step 4

    Safety and scar follow-up assessments

    During the study, the type, number, and seriousness of any local or systemic side effects are recorded. Local means near the injection area, and systemic means affecting the whole body.

    Your scars are also checked using the Manchester Scar Scale (MSS), which is based on standard photographs of the scar.

    Scar thickness is measured with ultrasound, which uses sound waves to look at the tissue under the skin.

    You also rate your own scar appearance and symptoms using the SCAR-Q Appearance Scale and SCAR-Q Symptom Scale. These are questionnaires about how the scar looks and how it feels to you.

Who can join the trial?

5 criteria

  • Must be scheduled to have an elective abdominoplasty, which is a planned tummy surgery, and the wound must be suitable for primary closure meaning it can be closed directly with stitches or similar methods.
  • Must be 18 years of age or older.
  • Must have an ASA class I or II health status. ASA is a doctor’s way of describing overall physical health before surgery; class I means a healthy person, and class II means a person with mild health problems that do not seriously limit daily life.
  • Must be able to give written informed consent, meaning the patient can understand the study, agree to join in writing, and is willing to follow the study rules and visits.
  • Must have Fitzpatrick skin type I, II, III, or IV. This is a skin color and sun-response scale: type I burns very easily, and type IV is light brown skin that tans more easily than it burns.

Who cannot join the trial?

14 criteria

  • Pregnancy or planning to become pregnant within the next 6 months.
  • Breastfeeding.
  • Autoimmune skin conditions, which are conditions where the immune system attacks the body’s own skin.
  • Fibrotic skin conditions, which cause too much scar-like tissue in the skin.
  • Use of photosensitizing medications, which are medicines that make the skin more sensitive to light.
  • Any other medical problem that the study doctor thinks could be a risk to safety or could affect the study results.
  • Smoking within the previous 6 months.
  • Excessive alcohol intake, meaning more than 10 units per week for women or more than 14 units per week for men.
  • Not being able to read, understand, and communicate in Danish well enough to give informed consent and follow study procedures. Informed consent means agreeing to take part after understanding the study.
  • Known conditions that cause abnormal scarring or other problems that affect wound healing, which is how the body repairs a wound.
  • Known allergy or sensitivity to verteporfin or any of its other ingredients.
  • Porphyria or other photosensitivity disorders, which are conditions that make the skin unusually sensitive to light.
  • Moderate liver dysfunction, meaning the liver is not working normally to a moderate degree.
  • Biliary obstruction, which means a blockage in the tubes that carry bile, a fluid made by the liver that helps with digestion.
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Investigated drugs

Verteporfin is the study drug being tested in this trial. It is given as an injection into the skin around surgical wounds. The goal is to see whether it can help prevent or reduce scarring after surgery by affecting the healing process in the wound area.

What is already known about the treatment

  • Verteporfin

    Verteporfin is given by injection, and in this study it is placed directly into the skin near the surgical wound. It is still known in medical literature and is used in medicine mainly as a light-activated drug for certain eye diseases, especially abnormal blood vessel growth in the retina. Its main use in this trial is to help prevent scar formation after surgery, and it is being studied for this new purpose. At the molecular level, verteporfin can block signals inside cells that help them grow and make scar tissue, especially by interfering with a pathway called YAP/TEAD, so it may reduce the body’s overactive wound-healing response. It is classified as a photosensitizing agent and an anti-scarring experimental treatment.

  • Saline

    Saline is given by injection, usually as a simple salt-water solution placed in the same way as the study drug. It is widely used in medicine and medical research as a safe, inactive solution for washing, dilution, or as a placebo control in clinical trials. In this study, it does not treat the wound itself and is used for comparison to help show whether verteporfin has an effect on scar prevention. Saline has no direct molecular action on scar formation because it does not contain an active medicine, and it is best described as an isotonic solution and placebo.

Investigated diseases

Scar formation following surgical wounds - Scar formation following surgical wounds is the development of scar tissue as a surgical wound heals. It begins when the skin closes after injury and may continue to change for months as the scar becomes flatter, firmer, and less red. The scar can vary in thickness, color, texture, and overall appearance. In some cases, the scar remains more noticeable because the healing process produces extra or uneven tissue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-525083-14-00Estimated enrolment12 patientsSponsorOdense University Hospital

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).