Scar formation following surgical wounds
Conditions
Brief summary
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., 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.
Detailed description
Safety and Tolerability: Incidence, severity, and type of local and systemic adverse events (AEs)., Manchester Scar Scale (MSS) based on standardized clinical photographs and ultrasound-based measurement of scar thickness, Time to Complete Epithelialization (Open Model Only): Days from punch biopsy creation to complete re-epithelialization., Patient Satisfaction: Patient's subjective assessment and satisfaction with each treated area using SCAR-Q Appearance Scale and SCAR-Q Symptom Scale
Interventions
DRUGVERTEPORFIN
DRUGSALINE
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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., 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability: Incidence, severity, and type of local and systemic adverse events (AEs)., Manchester Scar Scale (MSS) based on standardized clinical photographs and ultrasound-based measurement of scar thickness, Time to Complete Epithelialization (Open Model Only): Days from punch biopsy creation to complete re-epithelialization., Patient Satisfaction: Patient's subjective assessment and satisfaction with each treated area using SCAR-Q Appearance Scale and SCAR-Q Symptom Scale | — |
Outcome results
None listed