SCARFREE-001: Verteporfin for Scar Prevention

NCT07488988 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: SCARFREE-0012025-525083-14-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate whether the drug verteporfin can reduce the formation of scars in adult patients undergoing a tummy tuck procedure (abdominoplasty). The main questions the study aims to answer are:

• Whether treatment with verteporfin can reduce scar formation in surgical wounds that are closed with sutures, compared with placebo (saline). This will be assessed based on how the scars look after 3 months using a standardized scar assessment questionnaire (Patient and Observer Scar Assessment Scale).
• Whether treatment with verteporfin can reduce scar formation in small open wounds created after taking small tissue samples (4 mm), compared with placebo. This will also be assessed after 3 months using the same questionnaire. The researchers will compare three different doses of verteporfin (0.5 mg/mL, 1.0 mg/mL, and 2.0 mg/mL) with placebo. Each participant will receive all three doses as well as placebo, but in different areas of the surgical wound and in different small wounds, allowing comparisons to be made within the same person. Participants will:
• Undergo a planned abdominoplasty procedure
• During surgery, receive small injections in the skin with either verteporfin or placebo in different parts of the surgical wound.
• Have four small wounds (4 mm) created from tissue samples, which will also be treated with verteporfin or placebo.
• Attend follow-up visits after 1 week, 1 month, and 3 months, where the scars will be examined.
• Have photographs and ultrasound measurements taken of the scars.
• Complete questionnaires about their own assessment of the appearance of the scars.

Conditions

Surgical Scar

Keywords

Scar; Scar formation; Scar prevention; Scar therapy; Verteporfin; Visudyne

Outcome Measures

Primary Outcomes (1)

• POSAS (Patient and Observer Scar Assessment Scale)

  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 POSAS 3.0. Open wound endpoint: Difference in scar quality between three verteporfin doses (0.5, 1.0, 2.0 mg/mL) and placebo, assessed in punch biopsy wounds using the Observer component of the POSAS 3.0. POSAS Observer scores range from 10 (normal skin) to 50 (worst imaginable scar) and includes ten items assessing clinically relevant scar characteristics and overall scar quality. Each wound type (closed and open) will be evaluated independently.

  Month 3

Secondary Outcomes (5)

• Safety and Tolerability

  Day 7, month 1 and month 3

• MSS (Manchester Scar Scale)

  Month 3

• Ultrasound Assessment of Scar Thickness

  Month 1 and 3

• Photographic Documentation

  Day 7, month 1 and 3

• Patient-Reported Scar Outcomes using SCAR-Q Appearance Scale and SCAR-Q Symptom Scale

  Month 1 and 3

Study Arms (4)

Saline

PLACEBO COMPARATOR

Saline is used as placebo and administered to one segment of the closed wound and one open wound.

Drug: Saline injection

Verteporfin (0.5 mg/mL)

ACTIVE COMPARATOR

Will be administered to one segment of the closed wound and one open wound. This dose level is included to explore the minimal effective dose.

Drug: Verteporfin Injection

Verteporfin (1.0 mg/mL)

ACTIVE COMPARATOR

Will be administered to one segment of the closed wound and one open wound. This dose level reflects the optimal concentration in murine models.

Drug: Verteporfin Injection

Verteporfin (2.0 mg/mL)

ACTIVE COMPARATOR

Will be administered to one segment of the closed wound and one open wound. This dose level reflects the optimal concentration in porcine models.

Drug: Verteporfin Injection

Interventions

Verteporfin Injection DRUG

* Approved Generic Name: Verteporfin * Trade Name: Visudyne® * Chemical Class: Benzoporphyrin derivative * EU Substance No.: SUB00044MIG

Also known as: Visudyne

Verteporfin (0.5 mg/mL); Verteporfin (1.0 mg/mL); Verteporfin (2.0 mg/mL)

Saline injection DRUG

Sterile saline solution administered intradermally as placebo.

Also known as: Sodium chloride 0.9%

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Breastfeeding
• Smoking within the previous 6 months
• Excessive alcohol intake (\>10 units/week for women, \>14 units/week for men)
• Participants who are unable to read, understand and communicate in Danish sufficiently to provide informed consent and comply with study procedures
• Known conditions of pathological scarring or other conditions affecting wound healing
• Known hypersensitivity to verteporfin or any excipients
• Porphyria or other photosensitivity disorders
• Moderate hepatic dysfunction, defined as:
• AST or ALT \>1.2 × ULN
• Hypoalbuminemia or prolonged PT
• Biliary obstruction, defined as:
• ALP or GGT \>1.2 × ULN
• Abnormal bilirubin
• Autoimmune or fibrotic skin conditions including (but not limited to):
• \. Keloids or hypertrophic scars, scleroderma, lupus, GVD, morphea, lichen sclerosus, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (16)

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• Houle JM, Strong A. Clinical pharmacokinetics of verteporfin. J Clin Pharmacol. 2002 May;42(5):547-57. doi: 10.1177/00912700222011607.

  PMID: 12017349 BACKGROUND

• Azab M, Benchaboune M, Blinder KJ, Bressler NM, Bressler SB, Gragoudas ES, Fish GE, Hao Y, Haynes L, Lim JI, Menchini U, Miller JW, Mones J, Potter MJ, Reaves A, Rosenfeld PJ, Strong A, Su XY, Slakter JS, Schmidt-Erfurth U, Sorenson JA; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group; Verteporfin in Photodynamic Therapy (VIP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report no. 4. Retina. 2004 Feb;24(1):1-12. doi: 10.1097/00006982-200402000-00001.

  PMID: 15076937 BACKGROUND

• Qin Z, Xia W, Fisher GJ, Voorhees JJ, Quan T. YAP/TAZ regulates TGF-beta/Smad3 signaling by induction of Smad7 via AP-1 in human skin dermal fibroblasts. Cell Commun Signal. 2018 Apr 25;16(1):18. doi: 10.1186/s12964-018-0232-3.

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• Lin RY, Sullivan KM, Argenta PA, Peter Lorenz H, Scott Adzick N. Scarless human fetal skin repair is intrinsic to the fetal fibroblast and occurs in the absence of an inflammatory response. Wound Repair Regen. 1994 Oct;2(4):297-305. doi: 10.1046/j.1524-475X.1994.20411.x.

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• Mascharak S, desJardins-Park HE, Davitt MF, Griffin M, Borrelli MR, Moore AL, Chen K, Duoto B, Chinta M, Foster DS, Shen AH, Januszyk M, Kwon SH, Wernig G, Wan DC, Lorenz HP, Gurtner GC, Longaker MT. Preventing Engrailed-1 activation in fibroblasts yields wound regeneration without scarring. Science. 2021 Apr 23;372(6540):eaba2374. doi: 10.1126/science.aba2374.

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• Bessler NM; Vam Study Writing Committee. Verteporfin therapy in age-related macular degeneration (VAM): an open-label multicenter photodynamic therapy study of 4,435 patients. Retina. 2004 Aug;24(4):512-20. doi: 10.1097/00006982-200408000-00003.

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MeSH Terms

Conditions

Cicatrix

Interventions

Verteporfin; Sodium Chloride

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• David Hebbelstrup Jensen, MD, Ph.d.

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rikke Johansen

CONTACT

+4565414326; rikke.johansen2@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is conducted as a partially blinded trial. The operating surgeon administering the intradermal verteporfin is unblinded to ensure correct dose preparation and accurate placement of the IMP. Participants and outcome assessors remain blinded to treatment allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, intra-patient study. Each participant receives three doses of verteporfin (0.5 mg/mL, 1.0 mg/mL, 2.0 mg/mL) and placebo administered to different predefined areas of the surgical incision and to separate punch biopsy wounds. This allows comparison of treatments within the same participant.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)