Scar FormationPhase 1/2NCT06944249
Effect of YAP1-inhibition in Surgical Wounds.
A Phase 1/2 study testing Verteporfin Injection in people with Scar Formation, run by Jöri Pünchera.
Trial summary
When we get injured, our body naturally tries to heal. In adults, this healing often leads to scars - thick, stiff tissue known as fibrotic tissue. Unlike normal tissue, fibrotic tissue doesn't function properly and can cause serious health problems, depending on the affected organ. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Scar Formation
- What is being tested?
- Verteporfin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2025to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide informed consent as documented by signature
- Age is >/= 18 years and < 56 years (differently said: starting from the 18th birthday to completion of their 55 years)
- Indication for a safety margin excision (5 mm laterally) due to melanoma in situ or severe dysplastic nevi previously completely excised
- Length of initial scar from 15 mm to 50 mm
- The initial lesion was excised on the back (to ensure that all patients undergo their safety margin excision within the internationally accepted timeframe, we will also accept patients requiring the procedure at another anatomical site if a particular batch cannot be filled within 4 weeks of its first patient's enrollment)
Who cannot join
- Clinical adenopathy (cervical, axillar, inguinal) defined as a lymph node of more than 1 cm diameter
- Melanoma in situ of lentigo maligna or acral lentiginous type
- Head and neck location
- Diameter of initial lesion above or equal to 3 cm
- Known and documented hypersensitivity to Verteporfin or to any of its excipients: lactose monohydrate, egg phosphatidylglycerol (to simplify we will exclude patients with known and documented allergy to egg protein), dimyristoyl phosphatidylcholine, ascorbyl palmitate, butylated hydroxytoluene (E321)
- Porphyria
Show all 12Show fewer
- Moderate hepatic dysfunction referred to as any of the following: AST >1.2x upper normal range, ALT >1.2x upper normal range, decreased albumin level, prolongation of PT
- Biliary obstruction referred to as any of the following: ALP >1.2x upper normal range, GGT >1.2x upper normal range, anormal bilirubin level
- Pregnancy referred to as: positive beta-hCG blood test
- Breast-feeding
- Planned pregnancy in the next 6 months
- History of either one of the following: keloids, scleroderma, morphea, lupus erythematosus, nephrogenic systemic fibrosis, graft-versus-host disease, lichen sclerosus, eosinophilic fasciitis, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome, or pseudoxanthoma elasticum
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of YAP1 in Fibrosis Explored Through Its Local Inhibition With Verteporfin in Surgical Wounds: A Randomized Controlled, Prospective, Evaluator-blinded Proof-of-concept Study.
When we get injured, our body naturally tries to heal. In adults, this healing often leads to scars - thick, stiff tissue known as fibrotic tissue. Unlike normal tissue, fibrotic tissue doesn't function properly and can cause serious health problems, depending on the affected organ. Once it forms, fibrosis is usually permanent.
A good example of the fibrosis process is the healing of our skin: after a cut or surgery, the resulting scar is a type of fibrosis. Special cells called fibroblasts are key players in this process.
Read more
Our study looks at a drug called verteporfin, which is already approved both in Europe and the U.S. Previous research on mice and human cells suggests it can reduce or even prevent fibrosis.
We are now testing, clinically, histologically and by scRNA-seq, whether injecting verteporfin into the skin during wound healing, specifically after surgical procedures, can prevent thick, rigid scars from forming. Since the skin is easy to observe and sample, it offers a great model for studying this.
Will verteporfin have an impact on how surgical wounds heal? That's what we aim to find out.
- Conditions
- Scar Formation
- Being tested
- NaCl (placebo), Verteporfin Injection
- Keywords
- YAP1, Verteporfin, Scar, Fibrosis, Wound healing
- Medical subject headings
- Cicatrix, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl (placebo)Drug
During the safety margin excision, the placebo (NaCl) will be injected into the wound before suturing.
Verteporfin InjectionDrug
During the safety margin excision, the study drug (Verteporfin) will be injected into the wound before suturing.
| Study group | Role | What they receive |
|---|---|---|
| Study arm (verteporfin) | Experimental | Not described Receives: Drug: Verteporfin Injection |
| Placebo arm | Placebo comparator | Not described Receives: Drug: NaCl (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the profibrotic mesenchymal fibroblast subpopulation in the study group compared to the placebo group.
For comparison between groups, skin samples of the repaired tissue taken at visit 4 (Day 90 +/- 10) will be compared between the patients of both groups.
Measured: There are 90 +/- 10 days between visit 1 and visit 4.
Secondary outcomes (6)
The changes of fibroblast subpopulations, clusters, and their different cell-cell interactions in both groups before and after the study intervention.
For comparison over time in both groups, skin samples of the repaired tissue taken at visit 4 (Day 90 +/- 10) will be compared to the scar sample of visit 1 (Day 0) in all patients of both groups.
Measured: There are 90 +/- 10 days between visit 1 and visit 4.
Quantification of pilosebaceous units and profibrotic activity (quantity of collagen I and III and its ratio, fibronectin, α-SMA, nuclear localization of YAP1 and En1-staining) and its change over time
For comparison over time in both groups, skin samples of the repaired tissue taken at visit 4 (Day 90 +/- 10) will be compared to the scar sample of visit 1 (Day 0) in all patients of both groups.
Measured: There are 90 +/- 10 days between visit 1 and visit 4.
Quantification of the different fibroblast subpopulations in unwounded, healthy skin.
In all patients, 2 slices of the initial FFPE skin samples will be analyzed.
Measured: The initial excision will take place 21 to 54 days before V1.
The changes of different fibroblast subpopulations passing from unwounded skin to scarred, to repaired skin.
Analysis of the initial FFPE skin samples compared to the analysis on Day 0 and Day 90 (+/- 10).
Measured: There are a maximum of 56 days + 90 +/- 10 days between the inital mole removal and visit 4.
Comparison of the clinical outcomes of the scars in both groups.
The clinical outcomes will be evaluated by VSS scoring at visit 3 (Day 14 +/- 2), visit 4 (Day 90 +/- 10) and visit 5 (Day 180 +/- 10).
Measured: There are a minimum of 154 and a maximum of 178 days between visit 3 and visit 5.
The comparison of PROMs
PROMs will be assessed in both groups by SCAR-Q scoring at Day 14 (+/- 2), Day 90 (+/- 10) and Day 180 (+/- 10).
Measured: There are a minimum of 154 and a maximum of 178 days between visit 3 and visit 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start8 May 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Scar FormationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jöri Pünchera
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Jöri Pünchera, University Hospital, Geneva
- Investigators
- Jöri Pünchera, M.D., Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944249
- Sponsor's protocol ID
- CCER_Etude 2024- 00419
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the assessment of primary and secondary outcomes, will be shared in a coded, anonymized format via a secure repository in accordance with FAIR data principles and Open Research Data guidelines. Data will be made available to qualified researchers upon reasonable request following publication. Access may be subject to a data use agreement.
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.
PubMed 33888614Jiang D, Correa-Gallegos D, Christ S, Stefanska A, Liu J, Ramesh P, Rajendran V, De Santis MM, Wagner DE, Rinkevich Y. Two succeeding fibroblastic lineages drive dermal development and the transition from regeneration to scarring. Nat Cell Biol. 2018 Apr;20(4):422-431. doi: 10.1038/s41556-018-0073-8. Epub 2018 Mar 28.
PubMed 29593327Jiang D, Rinkevich Y. Converting fibroblastic fates leads to wound healing without scar. Signal Transduct Target Ther. 2021 Sep 1;6(1):332. doi: 10.1038/s41392-021-00738-6. No abstract available.
PubMed 34471094
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of YAP1 in Fibrosis Explored Through Its Local Inhibition With Verteporfin in Surgical Wounds: A Randomized Controlled, Prospective, Evaluator-blinded Proof-of-concept Study.
- ClinicalTrials.gov ID
- NCT06944249
- Acronym / sponsor ID
- CCER_Etude 2024- 00419
- Conditions
- Scar Formation
- Keywords
- YAP1, Verteporfin, Scar, Fibrosis, Wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jöri PüncheraUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, University Hospital, Geneva
- Study start
- 8 May 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When we get injured, our body naturally tries to heal. In adults, this healing often leads to scars - thick, stiff tissue known as fibrotic tissue. Unlike normal tissue, fibrotic tissue doesn't function properly and can cause serious health problems, depending on the affected organ. Once it forms, fibrosis is usually permanent.
A good example of the fibrosis process is the healing of our skin: after a cut or surgery, the resulting scar is a type of fibrosis. Special cells called fibroblasts are key players in this process.
Our study looks at a drug called verteporfin, which is already approved both in Europe and the U.S. Previous research on mice and human cells suggests it can reduce or even prevent fibrosis.
We are now testing, clinically, histologically and by scRNA-seq, whether injecting verteporfin into the skin during wound healing, specifically after surgical procedures, can prevent thick, rigid scars from forming. Since the skin is easy to observe and sample, it offers a great model for studying this.
Will verteporfin have an impact on how surgical wounds heal? That's what we aim to find out.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm (verteporfin) | Experimental | Drug: Verteporfin Injection |
| Placebo arm | Placebo comparator | Drug: NaCl (placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to provide informed consent as documented by signature
- Age is >/= 18 years and < 56 years (differently said: starting from the 18th birthday to completion of their 55 years)
- Indication for a safety margin excision (5 mm laterally) due to melanoma in situ or severe dysplastic nevi previously completely excised
- Length of initial scar from 15 mm to 50 mm
- The initial lesion was excised on the back (to ensure that all patients undergo their safety margin excision within the internationally accepted timeframe, we will also accept patients requiring the procedure at another anatomical site if a particular batch cannot be filled within 4 weeks of its first patient's enrollment)
Key exclusion criteria (12 listed)
- Clinical adenopathy (cervical, axillar, inguinal) defined as a lymph node of more than 1 cm diameter
- Melanoma in situ of lentigo maligna or acral lentiginous type
- Head and neck location
- Diameter of initial lesion above or equal to 3 cm
- Known and documented hypersensitivity to Verteporfin or to any of its excipients: lactose monohydrate, egg phosphatidylglycerol (to simplify we will exclude patients with known and documented allergy to egg protein), dimyristoyl phosphatidylcholine, ascorbyl palmitate, butylated hydroxytoluene (E321)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaCl (placebo)During the safety margin excision, the placebo (NaCl) will be injected into the wound before suturing. | Drug | Placebo arm |
| Verteporfin InjectionDuring the safety margin excision, the study drug (Verteporfin) will be injected into the wound before suturing. | Drug | Study arm (verteporfin) |
Primary outcome
Quantification of the profibrotic mesenchymal fibroblast subpopulation in the study group compared to the placebo group.
Time frame: There are 90 +/- 10 days between visit 1 and visit 4.
For comparison between groups, skin samples of the repaired tissue taken at visit 4 (Day 90 +/- 10) will be compared between the patients of both groups.
6 secondary outcomes
The changes of fibroblast subpopulations, clusters, and their different cell-cell interactions in both groups before and after the study intervention.
Time frame: There are 90 +/- 10 days between visit 1 and visit 4.
Quantification of pilosebaceous units and profibrotic activity (quantity of collagen I and III and its ratio, fibronectin, α-SMA, nuclear localization of YAP1 and En1-staining) and its change over time
Time frame: There are 90 +/- 10 days between visit 1 and visit 4.
Quantification of the different fibroblast subpopulations in unwounded, healthy skin.
Time frame: The initial excision will take place 21 to 54 days before V1.
The changes of different fibroblast subpopulations passing from unwounded skin to scarred, to repaired skin.
Time frame: There are a maximum of 56 days + 90 +/- 10 days between the inital mole removal and visit 4.
Comparison of the clinical outcomes of the scars in both groups.
Time frame: There are a minimum of 154 and a maximum of 178 days between visit 3 and visit 5.
The comparison of PROMs
Time frame: There are a minimum of 154 and a maximum of 178 days between visit 3 and visit 5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 33888614Mascharak 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: PubMed 29593327Jiang D, Correa-Gallegos D, Christ S, Stefanska A, Liu J, Ramesh P, Rajendran V, De Santis MM, Wagner DE, Rinkevich Y. Two succeeding fibroblastic lineages drive dermal development and the transition from regeneration to scarring. Nat Cell Biol. 2018 Apr;20(4):422-431. doi: 10.1038/s41556-018-0073-8. Epub 2018 Mar 28.
- Background: PubMed 34471094Jiang D, Rinkevich Y. Converting fibroblastic fates leads to wound healing without scar. Signal Transduct Target Ther. 2021 Sep 1;6(1):332. doi: 10.1038/s41392-021-00738-6. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the assessment of primary and secondary outcomes, will be shared in a coded, anonymized format via a secure repository in accordance with FAIR data principles and Open Research Data guidelines. Data will be made available to qualified researchers upon reasonable request following publication. Access may be subject to a data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jöri Pünchera, M.D. principal investigator
University Hospital, Geneva
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Verteporfin Injection in people with Scar Formation, run by Jöri Pünchera.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jöri Pünchera, M.D. (+41223729450, jpuc@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the profibrotic mesenchymal fibroblast subpopulation in the study group compared to the placebo group. (time frame: There are 90 +/- 10 days between visit 1 and visit 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944249, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.