Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
12
Countries
1
Sites
1
Scar formation following surgical wounds
To evaluate the preliminary efficacy and dose–response of intradermal verteporfin for scar prevention following surgery.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Decision date (initial)
- 2026-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Odense University Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Dose response, Prophylaxis
To evaluate the preliminary efficacy and dose–response of intradermal verteporfin for scar prevention following surgery.
Secondary objectives 4
- To assess the safety and tolerability of intradermal verteporfin at varying doses
- To evaluate scar outcomes using the Manchester Scar Scale (MSS) based on standardized clinical photographs, supplemented by ultrasound-based measurement of scar thickness
- To determine the time to complete epithelialization in open punch biopsy wounds
- To evaluate patient-reported satisfaction with scar appearance
Conditions and MedDRA coding
Scar formation following surgical wounds
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10057060 | Surgical scar | 10022117 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment and follow-up period Randomized, single blinded, placebo-controlled, intra-patient, single center clinical trial.
|
Randomised Controlled | Single | [{"id":182158,"code":4,"name":"Analyst"},{"id":182157,"code":1,"name":"Subject"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Scheduled to undergo elective abdominoplasty amenable to primary closure
- Age ≥ 18 years old
- ASA class I–II
- Ability to provide written and informed consent and willing to comply with study procedures
- Fitzpatrick skin type I-IV
Exclusion criteria 12
- 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 or biliary obstruction
- Autoimmune or fibrotic skin conditions
- Current use of photosensitizing medications
- Any medical condition deemed by the investigator to pose a risk to safety or data integrity
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 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 Patient and Observer Scar Assessment Scale (POSAS) at 3 months.
- Open wound endpoint: Difference in scar quality between the same three doses and placebo, assessed in punch biopsy wounds, also using Observer POSAS at 3 months.
Secondary endpoints 4
- Safety and Tolerability: Incidence, severity, and type of local and systemic adverse events (AEs).
- Manchester Scar Scale (MSS) based on standardized clinical photographs and ultrasound-based measurement of scar thickness
- Time to Complete Epithelialization (Open Model Only): Days from punch biopsy creation to complete re-epithelialization.
- Patient Satisfaction: Patient's subjective assessment and satisfaction with each treated area using SCAR-Q Appearance Scale and SCAR-Q Symptom Scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB00044MIG · Substance
- Active substance
- Verteporfin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 2.0 mg/ml milligram(s)/millilitre
- Max total dose
- 2.1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 2.0 mg/ml milligram(s)/millilitre
- Max total dose
- 2.1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J. B. Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- David Hebbelstrup Jensen
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- David Hebbelstrup Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-525083-14-00 | 2.3 |
| Protocol (for publication) | D4_Patient facing documents_DANISH SCAR-Q | 1 |
| Protocol (for publication) | Manchester-Scar-Scale | 1 |
| Protocol (for publication) | POSAS Observer-Scale Linear Scar - English | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 1.5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC verteporfin Danish | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-11 | Denmark | Acceptable 2026-05-05
|
2026-05-13 |