VERTEPORFIN for Scar formation following surgical wounds | Surgical scar

Inclusion criteria

• {"criterion_text":"- Scheduled to undergo elective abdominoplasty amenable to primary closure"}
• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- ASA class I–II"}
• {"criterion_text":"- Ability to provide written and informed consent and willing to comply with study procedures"}
• {"criterion_text":"- Fitzpatrick skin type I-IV"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or planned pregnancy within the next 6 months at the time of inclusion"}
• {"criterion_text":"- Breastfeeding"}
• {"criterion_text":"- Smoking within the previous 6 months"}
• {"criterion_text":"- Excessive alcohol intake (>10 units/week for women, >14 units/week for men)"}
• {"criterion_text":"- Participants who are unable to read, understand and communicate in Danish sufficiently to provide informed consent and comply with study procedures"}
• {"criterion_text":"- Known conditions of pathological scarring or other conditions affecting wound healing"}
• {"criterion_text":"- Known hypersensitivity to verteporfin or any excipients"}
• {"criterion_text":"- Porphyria or other photosensitivity disorders"}
• {"criterion_text":"- Moderate hepatic dysfunction or biliary obstruction"}
• {"criterion_text":"- Autoimmune or fibrotic skin conditions"}
• {"criterion_text":"- Current use of photosensitizing medications"}
• {"criterion_text":"- Any medical condition deemed by the investigator to pose a risk to safety or data integrity"}

Primary endpoints

• {"endpoint_text":"- 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 Patient and Observer Scar Assessment Scale (POSAS) at 3 months.","definition_or_measurement_approach":"Assessment using the Observer component of the Patient and Observer Scar Assessment Scale (POSAS) at 3 months, comparing three verteporfin doses (0.5, 1.0, 2.0 mg/mL) versus placebo in sutured incision segments."}
• {"endpoint_text":"- Open wound endpoint: Difference in scar quality between the same three doses and placebo, assessed in punch biopsy wounds, also using Observer POSAS at 3 months.","definition_or_measurement_approach":"Assessment using the Observer component of POSAS at 3 months in punch biopsy wounds comparing the three verteporfin doses (0.5, 1.0, 2.0 mg/mL) versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Safety and Tolerability: Incidence, severity, and type of local and systemic adverse events (AEs).","definition_or_measurement_approach":"Collection and reporting of incidence, severity and type of local and systemic adverse events (AEs) during study follow-up."}
• {"endpoint_text":"- Manchester Scar Scale (MSS) based on standardized clinical photographs and ultrasound-based measurement of scar thickness","definition_or_measurement_approach":"Scar assessment using Manchester Scar Scale on standardized clinical photographs supplemented by ultrasound measurement of scar thickness."}
• {"endpoint_text":"- Time to Complete Epithelialization (Open Model Only): Days from punch biopsy creation to complete re-epithelialization.","definition_or_measurement_approach":"Measured as days from punch biopsy creation to documented complete re-epithelialization."}
• {"endpoint_text":"- Patient Satisfaction: Patient's subjective assessment and satisfaction with each treated area using SCAR-Q Appearance Scale and SCAR-Q Symptom Scale","definition_or_measurement_approach":"Patient-reported outcomes using SCAR-Q Appearance and SCAR-Q Symptom scales for each treated area."}

Denmark

Earliest CTIS Part Ii Submission Date

12-05-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

1

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"1;7;8","organisation_type":"Hospital/Clinic/Other health care facility"}