SCARFREE-001: A Phase 2 Dose-Finding and Proof-of-Concept Study of Intradermal Verteporfin for Scar Prevention in Open and Closed Surgical Wounds

Condition studied

Scar formation following surgical wounds

Investigational medicinal product(s)

Every trial of Verteporfin across our registers →

Eligibility

Primary endpoint

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.

Endpoint detail

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