SCARFREE-001: Verteporfin for Scar Prevention

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.

Timeline

Start

2026-06

Primary completion

2028-02

Completion

2028-02

Publications

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• Background Mascharak S, Griffin M, Talbott HE, Guo JL, Parker J, Morgan AG, Valencia C, Kuhnert MM, Li DJ, Liang NE, Kratofil RM, Daccache JA, Sidhu I, Davitt MF, Guardino N, Lu JM, Abbas DB, Deleon NMD, Lavin CV, Adem S, Khan A, Chen K, Henn D, Spielman A, Cotterell A, Akras D, Downer M Jr, Tevlin R, Lorenz HP, Gurtner GC, Januszyk M, Naik S, Wan DC, Longaker MT. Inhibiting mechanotransduction prevents scarring and yields regeneration in a large animal model. Sci Transl Med. 2025 Feb 19;17(786):eadt6387. doi: 10.1126/scitranslmed.adt6387. Epub 2025 Feb 19.
• Background LaCanna R, Liccardo D, Zhang P, Tragesser L, Wang Y, Cao T, Chapman HA, Morrisey EE, Shen H, Koch WJ, Kosmider B, Wolfson MR, Tian Y. Yap/Taz regulate alveolar regeneration and resolution of lung inflammation. J Clin Invest. 2019 Apr 15;129(5):2107-2122. doi: 10.1172/JCI125014. eCollection 2019 Apr 15.
• Background Xin M, Kim Y, Sutherland LB, Murakami M, Qi X, McAnally J, Porrello ER, Mahmoud AI, Tan W, Shelton JM, Richardson JA, Sadek HA, Bassel-Duby R, Olson EN. Hippo pathway effector Yap promotes cardiac regeneration. Proc Natl Acad Sci U S A. 2013 Aug 20;110(34):13839-44. doi: 10.1073/pnas.1313192110. Epub 2013 Aug 5.
• Background Lu L, Finegold MJ, Johnson RL. Hippo pathway coactivators Yap and Taz are required to coordinate mammalian liver regeneration. Exp Mol Med. 2018 Jan 5;50(1):e423. doi: 10.1038/emm.2017.205.
• Background Houle JM, Strong A. Clinical pharmacokinetics of verteporfin. J Clin Pharmacol. 2002 May;42(5):547-57. doi: 10.1177/00912700222011607.
• 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.
• 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.
• Background Garoffolo G, Casaburo M, Amadeo F, Salvi M, Bernava G, Piacentini L, Chimenti I, Zaccagnini G, Milcovich G, Zuccolo E, Agrifoglio M, Ragazzini S, Baasansuren O, Cozzolino C, Chiesa M, Ferrari S, Carbonaro D, Santoro R, Manzoni M, Casalis L, Raucci A, Molinari F, Menicanti L, Pagano F, Ohashi T, Martelli F, Massai D, Colombo GI, Messina E, Morbiducci U, Pesce M. Reduction of Cardiac Fibrosis by Interference With YAP-Dependent Transactivation. Circ Res. 2022 Jul 22;131(3):239-257. doi: 10.1161/CIRCRESAHA.121.319373. Epub 2022 Jun 30.
• Background Liu Z, Wu H, Jiang K, Wang Y, Zhang W, Chu Q, Li J, Huang H, Cai T, Ji H, Yang C, Tang N. MAPK-Mediated YAP Activation Controls Mechanical-Tension-Induced Pulmonary Alveolar Regeneration. Cell Rep. 2016 Aug 16;16(7):1810-9. doi: 10.1016/j.celrep.2016.07.020. Epub 2016 Aug 4.
• Background Gao N, Lu L, Ma X, Liu Z, Yang S, Han G. Targeted inhibition of YAP/TAZ alters the biological behaviours of keloid fibroblasts. Exp Dermatol. 2022 Mar;31(3):320-329. doi: 10.1111/exd.14466. Epub 2021 Oct 19.
• Background 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.
• Background 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.
• Background Grijalva JL, Huizenga M, Mueller K, Rodriguez S, Brazzo J, Camargo F, Sadri-Vakili G, Vakili K. Dynamic alterations in Hippo signaling pathway and YAP activation during liver regeneration. Am J Physiol Gastrointest Liver Physiol. 2014 Jul 15;307(2):G196-204. doi: 10.1152/ajpgi.00077.2014. Epub 2014 May 29.
• Background 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.
• Background Dreno B, Amici JM, Demessant-Flavigny AL, Wright C, Taieb C, Desai SR, Alexis A. The Impact of Acne, Atopic Dermatitis, Skin Toxicities and Scars on Quality of Life and the Importance of a Holistic Treatment Approach. Clin Cosmet Investig Dermatol. 2021 Jun 14;14:623-632. doi: 10.2147/CCID.S315846. eCollection 2021.

Drugs

Indications

No indication recorded.