SCARFREE-001: Verteporfin for Scar Prevention
ConditionSurgical Scar
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Scheduled to undergo elective abdominoplasty amenable to primary closure
ASA class I-II
Fitzpatrick skin type I-IV
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Verteporfin Injection
Drug* Approved Generic Name: Verteporfin * Trade Name: Visudyne® * Chemical Class: Benzoporphyrin derivative * EU Substance No.: SUB00044MIG
Saline injection
DrugSterile saline solution administered intradermally as placebo.
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: SalinePlacebo comparator 1 intervention
Group B: Verteporfin (0.5 mg/mL)Active comparator 1 intervention
Group C: Verteporfin (1.0 mg/mL)Active comparator 1 intervention
Group D: Verteporfin (2.0 mg/mL)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Month 3Secondary outcomes
1
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.
Time frame
Day 7, month 1 and month 32
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).
Time frame
Month 33
Ultrasound Assessment of Scar Thickness
Quantitative measurement of dermal thickness using high-frequency ultrasound to assess fibrosis objectively.
Time frame
Month 1 and 34
Photographic Documentation
Standardized clinical photography.
Time frame
Day 7, month 1 and 3Sponsors and contacts
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Source ClinicalTrials.gov
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