Phase 2Recruiting
SCARFREE-001: Verteporfin for Scar Prevention
SCARFREE-001: A Phase 2 Dose-Finding and Proof-of-Concept Study of Intradermal Verteporfin for Scar Prevention in Open and Closed Surgical Wounds
- Sponsor
- Odense University Hospital (Academic or other)
- Enrollment
- 12 planned
- Conditions
- Surgical Scar
- Interventions
- Verteporfin Injection; Saline injection
- Ages
- adults, older adults
- Registry
- NCT07488988, CTIS2025-525083-14-00
Full record on ClinicalTrials.gov
From the registry
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.…
Primary outcomes
- POSAS (Patient and Observer Scar Assessment Scale)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered