Verteporfin for Scar Prevention after Abdominoplasty
Official title: SCARFREE-001: A Phase 2 Dose-Finding and Proof-of-Concept Study of Intradermal Verteporfin for Scar Prevention in Open and Closed Surgical Wounds
Run by Odense University Hospital · NCT07488988 · Data updated 2026-11-12
This study tests whether verteporfin can reduce scar formation after an abdominoplasty, comparing three doses to saline in different wound areas within the same participants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | August 2028 |
| Study ends | November 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07488988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older scheduled for elective abdominoplasty with primary wound closure and overall good health (ASA I–II).
✕Probably not a fit
Patients with known photosensitivity, liver dysfunction, pregnancy plans, or conditions affecting wound healing may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial investigates the effect of verteporfin on scar formation in adults undergoing elective abdominoplasty. Participants receive four wound-area treatments: three verteporfin dose levels (0.5, 1.0, and 2.0 mg/mL) and placebo, each in a distinct area of the surgical site or biopsy wound. Outcomes are assessed at 3 months using a standardized scar assessment scale. The study aims to see if transient verteporfin exposure can modulate the YAP/TAZ pathway to reduce fibrotic scarring compared with placebo, across both closed surgical wounds and small open biopsy wounds.
Why it matters
Potential benefit: If successful, verteporfin could decrease scar size and improve scar appearance after surgery.
How similar studies have gone: Previous research suggests YAP/TAZ pathway modulation can affect scarring; verteporfin has shown anti-fibrotic signals in preclinical models, with limited human data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Odense University Hospital
Odense, Denmark Recruiting
Study contacts
- Principal investigator: David Hebbelstrup Jensen, MD, Ph.d. — Odense University Hospital
- Study coordinator: Rikke Johansen
- Email: rikke.johansen2@rsyd.dk
- Phone: +4565414326
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.