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SCARFREE-001: Verteporfin for Scar Prevention

RecruitingPhase 2Ages 18 Years - anyAllOdense University Hospital
NCT07488988 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 part

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. AST or ALT \>1.2 × ULN 2. Hypoalbuminemia or prolonged PT * Biliary obstruction, defined as: 1. ALP or GGT \>1.2 × ULN 2. Abnormal bilirubin * Autoimmune or fibrotic skin conditions including (but not limited to): 1\. 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
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What it tests

  • Verteporfin Injection
  • Saline injection
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Where

1 site
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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