SCARFREE-001: Verteporfin for Scar Prevention
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Surgical Scar
In brief
The purpose of this clinical trial is to investigate whether the drug verteporfin can reduce the formation of scars in adult patients undergoing a tummy tuck procedure (abdominoplasty). The main questions the study aims to answer are: * Whether treatment with verteporfin can reduce scar formation in surgical wounds that are closed with sutures, compared with placebo (saline). This will be assessed based on how the scars look after 3 months using a standardized scar assessment questionnaire (Patient and Observer Scar Assessment Scale). * Whether treatment with verteporfin can reduce scar formation in small open wounds created after taking small tissue samples (4 mm), compared with placebo. This will also be assessed after 3 months using the same questionnaire. The researchers will compare three different doses of verteporfin (0.5 mg/mL, 1.0 mg/mL, and 2.0 mg/mL) with placebo. Each participant will receive all three doses as well as placebo, but in different areas of the surgical wound and in different small wounds, allowing comparisons to be made within the same person. Participants will: * Undergo a planned abdominoplasty procedure * During surgery, receive small injections in the skin with either verteporfin or placebo in different parts of the surgical wound. * Have four small wounds (4 mm) created from tissue samples, which will also be treated with verteporfin or placebo. * Attend follow-up visits after 1 week, 1 month, and 3 months, where the scars will be examined. * Have photographs and ultrasound measurements taken of the scars. * Complete questionnaires about their own assessment of the appearance of the scars.
Key facts
- Study ID
- NCT07488988
- Run by
- Odense University Hospital
- People needed
- 12
- Starts
- 2026-06-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years old
- Scheduled to undergo elective abdominoplasty amenable to primary closure
- ASA class I-II
- Fitzpatrick skin type I-IV
- Ability to provide written and informed consent and willing to comply with study procedures
You may not qualify if…
- Pregnancy or planned pregnancy within the next 6 months at the time of inclusion
- Breastfeeding
- Smoking within the previous 6 months
- Excessive alcohol intake (>10 units/week for women, >14 units/week for men)
- Participants who are unable to read, understand and communicate in Danish sufficiently to provide informed consent and comply with study procedures
- Known conditions of pathological scarring or other conditions affecting wound healing
- Known hypersensitivity to verteporfin or any excipients
- Porphyria or other photosensitivity disorders
- Moderate hepatic dysfunction, defined as:
- AST or ALT >1.2 × ULN
- Hypoalbuminemia or prolonged PT
- Biliary obstruction, defined as:
- ALP or GGT >1.2 × ULN
- Abnormal bilirubin
- Autoimmune or fibrotic skin conditions including (but not limited to):
- Keloids or hypertrophic scars, scleroderma, lupus, GVD, morphea, lichen sclerosus, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome
- Current use of photosensitizing medications (e.g. tetracyclines, thiazides, phenothiazines)
- Any medical condition deemed by the investigator to pose a risk to safety or data integrity
Where it is running
- Odense University Hospital — Odense, Denmark
Full record on ClinicalTrials.gov
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