SCARFREE-001: Verteporfin for Scar Prevention

ConditionSurgical Scar
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years old

Scheduled to undergo elective abdominoplasty amenable to primary closure

ASA class I-II

Fitzpatrick skin type I-IV

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Verteporfin Injection
  • Saline injection

Treatment groups

12 Participants
are divided into 4 treatment groups

Sponsors and collaborators