SCARFREE-001: Verteporfin for Scar Prevention

Sponsor
Odense University Hospital
Study ID
NCT07488988
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Surgical Scar

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verteporfin Injection — DRUG
    * Approved Generic Name: Verteporfin * Trade Name: Visudyne® * Chemical Class: Benzoporphyrin derivative * EU Substance No.: SUB00044MIG
  • Saline injection — DRUG
    Sterile saline solution administered intradermally as placebo.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Saline
    Saline is used as placebo and administered to one segment of the closed wound and one open wound.
  • Active Comparator: Verteporfin (0.5 mg/mL)
    Will be administered to one segment of the closed wound and one open wound. This dose level is included to explore the minimal effective dose.
  • Active Comparator: Verteporfin (1.0 mg/mL)
    Will be administered to one segment of the closed wound and one open wound. This dose level reflects the optimal concentration in murine models.
  • Active Comparator: Verteporfin (2.0 mg/mL)
    Will be administered to one segment of the closed wound and one open wound. This dose level reflects the optimal concentration in porcine models.

Primary Outcome Measure

POSAS (Patient and Observer Scar Assessment Scale) [ Time Frame: Month 3 ]

Central Contacts