SCARFREE-001: Verteporfin for Scar Prevention

Condition(s) studied

Investigational drug(s) / intervention(s)

Verteporfin Injection: * Approved Generic Name: Verteporfin * Trade Name: Visudyne® * Chemical Class: Benzoporphyrin derivative * EU Substance No.: SUB00044MIG

Saline injection: Sterile saline solution administered intradermally as placebo.

Study summary

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

Primary outcome measure(s)

• POSAS (Patient and Observer Scar Assessment Scale) — Month 3
  Closed wound endpoint: Difference in scar quality between three verteporfin doses (0.5, 1.0, 2.0 mg/mL) and placebo, assessed in sutured incision segments using the Observer component of the POSAS 3.0. Open wound endpoint: Difference in scar quality between three verteporfin doses (0.5, 1.0, 2.0 mg/mL) and placebo, assessed in punch biopsy wounds using the Observer component of the POSAS 3.0. POSAS Observer scores range from 10 (normal skin) to 50 (worst imaginable scar) and includes ten items assessing clinically relevant scar characteristics and overall scar quality. Each wound type (closed and open) will be evaluated independently.

Trial sites (1)

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