SCARFREE-001: Verteporfin for Scar Prevention (SCARFREE-001)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Scar
• Intervention / Treatment: Drug: Saline injection; Drug: Verteporfin Injection

Detailed Description

Introduction and Background:

Scar formation after skin injury represents a significant medical challenge with both physical and psychosocial consequences. Scars can cause pain, pruritus, restricted movement, and substantial psychological distress.

While adult wound healing typically results in scar formation, fetal wounds heal with minimal or no scarring, suggesting that regenerative, scarless healing is biologically possible under specific conditions. Recent research has identified the Yes-Associated Protein (YAP)/ Transcriptional Co-Activator with PDZ-binding motif (TAZ) signaling pathway as central to fibrosis development. Inhibition of this pathway has shown promising results in experimental fibrosis models.

YAP is a mechano-sensitive transcription coactivator regulated by the Hippo pathway. Its activity has emerged as a key determinant of whether injured tissues undergo regenerative healing (restoring normal structure) or fibrotic repair (scar formation). Recent studies across multiple organs indicate that the timing and duration of YAP activity is critical: Transient or timely YAP modulation can promote regeneration, whereas sustained YAP activation or complete loss of YAP often skews healing toward fibrosis.

Verteporfin is a Food and Drug Administration (FDA)-approved benzoporphyrin derivative used for treating macular degeneration that also inhibits the YAP/TAZ pathway. Animal studies have demonstrated that verteporfin reduces extracellular matrix deposition in liver, kidney, and retinal fibrosis. Most notably, Mascharak et al. recently showed that a single dose of verteporfin induced scarless wound healing in the Duroc pig, a model with skin healing characteristics closely resembling those of humans. The results were further validated using a human foreskin graft model in nude mice. Despite these promising preclinical results, human evidence for verteporfin's potential as a scar-preventing treatment is lacking. This study represents the first attempt to translate these findings into clinical practice.

Aim:

The aim of this study is to evaluate the safety and tolerability and to identify the most appropriate dose of intradermal verteporfin for the prevention of scar formation in surgical wounds. The results will pave the way for subsequent studies to further investigate the efficacy of verteporfin's anti-fibrotic properties.

Hypothesis:

It is hypothesized that a single intradermal administration of verteporfin at the time of surgery will result in a significant reduction in scar formation compared to placebo. Furthermore, a dose-response relationship is expected, with higher concentrations leading to greater improvement in scar quality without compromising wound healing. Finally, it is hypothesized that the treatment to be safe and well tolerated in humans with no serious adverse effects.

Study Design:

This trial is a phase 2, prospective, randomized, single blinded, placebo-controlled, intra-patient, single center clinical trial where each participant serves as their own control with different dose levels administered to different parts of the wound and different open wounds within the same patient. The total participation period for the individual subjects is 3 months.

The single-blinded study design (blinding of participants and outcome assessors, with the operating surgeon unblinded) was selected due to the visible dark green color of verteporfin, which makes full blinding difficult during administration. An intra-patient design was chosen to minimize inter-patient variability in wound healing.

Randomization and blinding:

Treatment allocation will be randomized using a computer-generated sequence to assign verteporfin dose levels and placebo to wound areas and punch biopsies within each participant.

Sample Size:

A total of 12 participants has been chosen as an appropriate sample size for this study. Due to the intra-patient design, where each participant contributes eight scar outcomes (four closed and four open wounds), a total of 96 observations will be available for safety assessment, exploratory dose-response analysis and estimation of effect. The underlying statistical considerations are presented below:

Fixed effect: treatment dose; random effect: participant. Pairwise comparisons between each verteporfin dose and placebo will be performed using a mixed-effects model with Dunnett's adjustment for multiple testing.

Based on previous scar studies, a 6-point difference in POSAS is considered clinically meaningful. Assuming a standard deviation of 5-7 points and intra-subject correlation of 0.3: With 12 participants, each contributing 4 scars per model (closed and open). The design yields sufficient power (≥80%, α = 0.025 per endpoint after Bonferroni correction). Total of 48 observations per model, supporting separate detection of meaningful differences in both scar types.

Methods:

Verteporfin will be administered by intradermal injection into wound margins at three dose levels:

• 0.5 mg/mL
• 1.0 mg/mL
• 2.0 mg/mL. These dose levels have been established based on preclinical findings on verteporfin's anti-fibrotic properties where 2.0 mg/mL represents the optimal dose in porcine models (with higher doses showing reduced efficacy), 1.0 mg/mL represents the optimal dose in murine models and 0.5 mg/mL is included to determine the minimal effective dose.

The drug will be administered after suture in the closed model, and after punch creation in the open model. Punch biopsies will be obtained from the lower abdomen within the pubic hair-bearing region to evaluate whether hair regrowth occurs as part of the regenerative process and to minimize the visibility of any scars resulting from the biopsies. No light activation will be used in this study. Each participant will receive all three dose levels plus one placebo (saline injection) in separate wound segments and separate punch biopsies. A single administration will take place on Day 0 (day of surgery) with no repeat dosing. This timing exploits the critical early YAP/TAZ modulation window.

Participants will be monitored at preplanned follow-up visits on Day 7, Month 1 and Month 3 where scar quality will be assessed via the primary endpoint for both the closed and open model:

• The Patient and Observer Scar Assessment Scale (POSAS) at 3 months. POSAS scores range from 6 (normal skin) to 60 (worst imaginable scar) and include six clinical parameters: Vascularity, pigmentation, thickness, relief, pliability and surface area. The endpoint is defined as the difference in POSAS score between verteporfin-treated sites and placebo-treated sites within each participant.

Study Limitations:

This study has several limitations. Firstly, the small sample size of 12 participants and the single-centre design limit the generalizability of the findings and the ability to detect rare adverse events or establish clinical efficacy. Secondly, the study population consists of healthy adults undergoing elective abdominoplasty which provides a homogeneous wound model but does not reflect high-risk groups such as patients with diabetes, smokers or individuals prone to hypertrophic scarring, therefore external validity is limited.

The follow-up period of 3 months fails to capture the long-term phases of scar maturation. Additionally, inter-patient dose comparison - while reducing inter-individual variability - introduces the possibility of local interference between the scar segments. Moreover, several outcome measures rely on subjective scar assessment tools (e.g. POSAS, MSS, SCAR-Q) which - despite being validated - carry a risk of observer bias even under blinded evaluation. These limitations will be addressed in future trials with larger study populations, longer follow-up and multicenter variation as well as inclusion of high-risk groups.

Feasibility:

The intra-patient design significantly enhances feasibility by reducing the required sample size as each participant contributes four treatment sites per wound model (open and closed). Recruitment is therefore considered realistic, as eligible patients are routinely available among those undergoing elective abdominoplasty at Odense University Hospital. All study procedures are integrated into the routine surgical workflow and three follow-up visits consisting only of non-invasive assessments are planned, minimizing participant burden and risk of withdrawal.

The research team has full access to surgical facilities, ultrasound equipment and clinical photography tools. Furthermore, the investigational medicinal product, verteporfin, has an established safety profile in humans in other indications, and only a single, local administration is required per participant. Together, these factors ensure that the study is practically, logistically and ethically feasible.

Risks, Adverse Events, and Potential Disadvantages:

Verteporfin has an established safety profile in ocular use but is administered differently in this study. Therefore, additional or previously unobserved adverse effects may occur.

Possible adverse events include:

Common, non-serious adverse events

• Mild tenderness, redness, or swelling at the injection sites.

Rare or potentially serious adverse events

• Allergic reaction to verteporfin.
• Infection related to the injection procedure or the collection of tissue samples (punch biopsies).

Potential longer-term effects

• Changes in the cosmetic appearance or irregularity of the scar.
• Tissue stiffness in the area surrounding the scar.
• Small scars resulting from the punch biopsy procedures.

As with any clinical study, there may be risks that are currently unknown. Participants will therefore be asked to inform the study team if they experience any health-related problems during the course of the study. If new or previously unrecognized adverse effects are identified during the study, participants will be informed promptly and will have the opportunity to decide whether they wish to continue their participation.

Novelty:

This study is the first clinical trial to investigate intradermal verteporfin to reduce scarring in humans. Most available scar treatments focus on symptomatic treatment of cosmetic symptoms addressing established scars rather than preventing their formation. This project offers a unique possibility to introduce a new concept of pharmacological therapy targeting the biological mechanisms of fibrosis (YAP/TAZ signaling pathway) at the time of injury. This study therefore generates safety and preliminary efficacy data for a completely new therapeutic indication of verteporfin with significant translational potential and large global clinical relevance.

Clinical Impact:

Excessive scarring remains a major unmet clinical challenge with functional, aesthetic, and psychological consequences affecting millions of patients worldwide every year. Current treatment options are limited in efficacy and primarily reactive as they largely focus on the management of established scars rather than prevention.

If successful, this study could introduce a paradigm shift in postoperative wound care by demonstrating that scarring can be modulated at the time of injury through targeted biological intervention. Intradermal verteporfin has the potential to become the first pharmacological therapy to actively reduce scar formation by inhibiting fibrotic signaling pathways.

The clinical impact is substantial: Improved patient satisfaction after surgeries with better functional and aesthetic outcomes and significant cost savings for healthcare systems. The findings from this study could benefit a wide range of surgical fields, including plastic and reconstructive surgery, orthopedics, general surgery and dermatology. Ultimately, by bridging strong preclinical evidence with clinical data, this study has the potential to lay the foundation for a new standard of care in scar prevention and personalized wound management.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rikke Johansen; Phone Number: +4565414326; Email: rikke.johansen2@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital
    • Contact: Rikke Johansen, Cand.scient.san.publ; Phone Number: +4565414326; Email: rikke.johansen2@rsyd.dk
    • Principal Investigator: David Hebbelstrup Jensen, MD, Ph.d.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy or planned pregnancy within the next 6 months at the time of inclusion
• 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:

  1. AST or ALT >1.2 × ULN
  2. Hypoalbuminemia or prolonged PT

• Biliary obstruction, defined as:

  1. ALP or GGT >1.2 × ULN
  2. Abnormal bilirubin

• Autoimmune or fibrotic skin conditions including (but not limited to):

  1. Keloids or hypertrophic scars, scleroderma, lupus, GVD, morphea, lichen sclerosus, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome

• Current use of photosensitizing medications (e.g. tetracyclines, thiazides, phenothiazines)
• Any medical condition deemed by the investigator to pose a risk to safety or data integrity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Saline is used as placebo and administered to one segment of the closed wound and one open wound.	Drug: Saline injection; Sterile saline solution administered intradermally as placebo.; Other Names: Sodium chloride 0.9%
Active Comparator: Verteporfin (0.5 mg/mL); 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; Approved Generic Name: Verteporfin; Trade Name: Visudyne®; Chemical Class: Benzoporphyrin derivative; EU Substance No.: SUB00044MIG; Other Names: Visudyne
Active Comparator: Verteporfin (1.0 mg/mL); 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; Approved Generic Name: Verteporfin; Trade Name: Visudyne®; Chemical Class: Benzoporphyrin derivative; EU Substance No.: SUB00044MIG; Other Names: Visudyne
Active Comparator: Verteporfin (2.0 mg/mL); 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; Approved Generic Name: Verteporfin; Trade Name: Visudyne®; Chemical Class: Benzoporphyrin derivative; EU Substance No.: SUB00044MIG; Other Names: Visudyne

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Incidence, severity and type of local and systemic adverse events, including but not limited to injection site reactions, delayed wound healing, infections and systemic symptoms.	Day 7, month 1 and month 3
MSS (Manchester Scar Scale)	A clinician-rated scar assessment scale designed for the evaluation of linear surgical scars, primarily based on visual inspection. Total score ranges from 5 to 18 (higher scores indicate worse scar quality). Evaluation will be performed based on standardized clinical photographs. Scale modification The "texture" component (item 5) is omitted, as assessments are performed exclusively based on standardized photographs and do not include physical examination. Therefore, the total score with the modified scale ranges from 4 to 14 (higher scores indicate worse scar quality).	Month 3
Ultrasound Assessment of Scar Thickness	Quantitative measurement of dermal thickness using high-frequency ultrasound to assess fibrosis objectively.	Month 1 and 3
Photographic Documentation	Standardized clinical photography.	Day 7, month 1 and 3
Patient-Reported Scar Outcomes using SCAR-Q Appearance Scale and SCAR-Q Symptom Scale	The SCAR-Q is a validated patient-reported outcome measure designed to assess scar appearance and scar-related symptoms from the patient's perspective. The Appearance and Symptom scales are scored separately. Each scale consists of 12 items rated on a 4-point Likert scale (each likert scale ranges from 12 to 48 with higher scores indicating better outcomes). Likert scores are converted to Rasch-transformed scores ranging from 0 to 100 where higher scores indicate better outcomes (i.e., more favourable appearance or fewer symptoms).	Month 1 and 3

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: David Hebbelstrup Jensen, MD, Ph.d., Odense University Hospital

Publications and helpful links

General Publications

• 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.
• Gaynes BI, Fiscella RG. Safety of verteporfin for treatment of subfoveal choroidal neovascular membranes associated with age-related macular degeneration. Expert Opin Drug Saf. 2004 Jul;3(4):345-61. doi: 10.1517/14740338.3.4.345.
• 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.
• 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.
• 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.
• 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.
• Houle JM, Strong A. Clinical pharmacokinetics of verteporfin. J Clin Pharmacol. 2002 May;42(5):547-57. doi: 10.1177/00912700222011607.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Visudyne; Verteporfin; Scar; Scar formation; Scar prevention; Scar therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Pathological Conditions, Signs and Symptoms; Cicatrix; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Heterocyclic Compounds, 4 or More Rings; Pyrroles; Macrocyclic Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Porphyrins; Tetrapyrroles; Verteporfin; Sodium Chloride
• Other Study ID Numbers: SCARFREE-001; 2025-525083-14-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to data protection regulations and patient confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes