Status:
NOT_YET_RECRUITING
Effect of YAP1-inhibition in Surgical Wounds.
Lead Sponsor:
Jöri Pünchera
Collaborating Sponsors:
University of Geneva, Switzerland
University Hospital, Geneva
Conditions:
Scar Formation
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
When we get injured, our body naturally tries to heal. In adults, this healing often leads to scars - thick, stiff tissue known as fibrotic tissue. Unlike normal tissue, fibrotic tissue doesn't functi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06944249
Start Date
May 8 2025
End Date
July 31 2026
Last Update
April 25 2025
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