Effect of YAP1-inhibition in Surgical Wounds.

Launched by JÖRI PÜNCHERA · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a drug called verteporfin to see if it can help prevent thick, stiff scars from forming on the skin after surgery. When our skin heals from an injury, it can sometimes form a type of tissue called fibrosis, which does not work like normal skin and can lead to health issues. The researchers want to find out if injecting verteporfin into surgical wounds can improve the healing process and reduce scar formation.

To participate in this trial, you need to be between 18 and 55 years old and have a specific type of skin surgery for melanoma or severe skin changes. You will also need to be willing to sign a consent form showing that you understand the study. However, there are some health conditions and other factors that might prevent you from joining, such as allergies to the drug or certain medical conditions. If you are eligible and decide to participate, you will be closely monitored during your healing process to see how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to provide informed consent as documented by signature
• • Age is \>/= 18 years and \< 56 years (differently said: starting from the 18th birthday to completion of their 55 years)
• • Indication for a safety margin excision (5 mm laterally) due to melanoma in situ or severe dysplastic nevi previously completely excised
• • Length of initial scar from 15 mm to 50 mm
• • The initial lesion was excised on the back (to ensure that all patients undergo their safety margin excision within the internationally accepted timeframe, we will also accept patients requiring the procedure at another anatomical site if a particular batch cannot be filled within 4 weeks of its first patient's enrollment)
• Exclusion Criteria:
• • Clinical adenopathy (cervical, axillar, inguinal) defined as a lymph node of more than 1 cm diameter
• • Melanoma in situ of lentigo maligna or acral lentiginous type
• • Head and neck location
• • Diameter of initial lesion above or equal to 3 cm
• • Known and documented hypersensitivity to Verteporfin or to any of its excipients: lactose monohydrate, egg phosphatidylglycerol (to simplify we will exclude patients with known and documented allergy to egg protein), dimyristoyl phosphatidylcholine, ascorbyl palmitate, butylated hydroxytoluene (E321)
• • Porphyria
• • Moderate hepatic dysfunction referred to as any of the following: AST \>1.2x upper normal range, ALT \>1.2x upper normal range, decreased albumin level, prolongation of PT
• • Biliary obstruction referred to as any of the following: ALP \>1.2x upper normal range, GGT \>1.2x upper normal range, anormal bilirubin level
• • Pregnancy referred to as: positive beta-hCG blood test
• • Breast-feeding
• • Planned pregnancy in the next 6 months
• • History of either one of the following: keloids, scleroderma, morphea, lupus erythematosus, nephrogenic systemic fibrosis, graft-versus-host disease, lichen sclerosus, eosinophilic fasciitis, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome, or pseudoxanthoma elasticum