An interventional study of TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. and 808 nm near-infrared (NIR) diode laser (Hyper Diode 808) in Nodular BCC, sponsored by Torskal SAS. Not yet recruiting at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Torskal SAS · Not applicable, Interventional, and Treatment
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Investigational Device
Dose regimen TSK-001
Laser Device
Near-infra red (NIR) irradiation of the tumour will be performed 1 hour after each injection of TSK-001 at the following laser settings:
Comparator N/A
Treatment Groups Part 1:
Part 1 consists of 3 single dose escalation cohorts:
Part 2:
Part 2 consists of a multiple dose expansion cohort who will receive two injections of TSK-001 at the MAD or MTD administered 2 weeks apart.
Part 3:
Part 3 consists of a Phase 2 multiple dose cohort who will receive two injections of TSK-001 at the RP2D administered 2 weeks apart.
Objectives Primary Objectives Part 1 To assess the safety and tolerability of a single administration of TSK001 combined with NIR irradiation in patients with nodular Basal Cell Carcinoma (nBCC).
Part 2 To assess the safety and tolerability of two administrations of TSK-001 combined with NIR irradiation in patients with nBCC.
Part 3 To assess Complete Response (CR) (disappearance of cutaneous tumour) of the target lesion using RECIST v1.1 criteria following two administrations of TSK-001 combined with NIR irradiation in patients with nBCC.
Secondary Objectives Part 1
Part2
Part 3:
Endpoints Primary endpoints Parts 1 and 2
Part 3:
Secondary endpoints Part 1
This is an open-label, multicentre, first-in-human, dose-escalation and expansion study designed to evaluate the safety, tolerability and performance of TSK-001 (glucose-coated plasmonic gold nanoparticles) used in combination with near-infrared (NIR) laser irradiation in adult men and women with nodular basal cell carcinoma (nBCC). A maximum of 78 patients is planned to be enrolled.
The study is divided into three parts.
Part 1 - Dose escalation
Part 1 consists of 3 dose-escalation cohorts designed to determine the maximum tolerated dose (MTD) or, if not reached, the maximum administered dose (MAD). Patients receive a single intratumoural injection of TSK-001, followed 1 hour later by NIR irradiation of the tumour. Three dose levels, expressed as a percentage of the tumour volume (volume/volume, vol/vol), will be evaluated:
Three patients are allocated to each new dose level. Each dose level starts with a sentinel patient; if no dose-limiting toxicity (DLT) is observed during a 29-day observation period, the remaining 2 patients may be enrolled in parallel. If a DLT is observed in 1 of 3 patients, 3 additional patients are enrolled at the same dose level. If 2 or more patients experience a DLT at a given dose level, recruitment into that cohort is stopped and the dose is de-escalated until a dose level is reached at which no more than 1 of 6 patients has a DLT; this dose level is defined as the MTD. If no further DLTs are observed, escalation continues to the next dose level. Intermediate dose levels may be introduced to ensure patient safety and better define the MTD. If no more than 1 DLT is observed at the highest dose (20% vol/vol), 3 additional patients are treated at that level; if no more than 1 of these 6 patients has a DLT, this dose is defined as the MAD.
Part 2 - Dose expansion Part 2 starts once the MTD or MAD has been determined and aims to identify the recommended Phase 2 dose (RP2D). Patients receive 2 intratumoural injections of TSK-001 at the MTD or MAD, 2 weeks apart, each followed 1 hour later by NIR irradiation. Six patients will be enrolled initially (maximum 12). If 2 or more patients experience a DLT, recruitment is stopped and the dose may be de-escalated in 6 new patients. If no more than 1 patient experiences a DLT, the study proceeds to Part 3 at the tested dose. The SRC reviews safety data throughout the study and is responsible for de-escalation decisions.
Part 3 - Phase 2 extension Up to 42 patients with nBCC will receive 2 intratumoural injections of TSK-001 at the RP2D identified in Part 2, 2 weeks apart, each followed 1 hour later by NIR irradiation. If 2 or more patients experience a DLT, recruitment will be stopped and a lower dose may be considered.
Lesion temperature monitoring Lesion temperature is monitored with an infrared thermography device during irradiation. The target therapeutic temperature range is 42-45 °C.
Pharmacokinetic (PK) sub-study A total of 12 patients from Parts 1 and 2 (3 per Part 1 cohort and 3 in Part 2) will take part in the PK sub-study. Blood samples will be collected before treatment, 60 minutes after the first injection on Day 1, and 24 hours after the first injection (Day 2). Urine will be collected 0-24 hours and 24-48 hours after the first injection.
Statistical analysis A detailed Statistical Analysis Plan (SAP) will be finalised before the first patient's visit. Safety endpoints will be analysed descriptively and presented by study part and dose group. Continuous variables will be summarised by number of non-missing values, mean, standard deviation (SD), median, minimum and maximum; categorical variables by frequency counts and percentages. Where required, two-sided 95% confidence intervals (CIs) will be calculated and significance testing will use a two-sided 5% significance level. Missing data will not be imputed.
Analysis sets:
Sample size:
This is the only study on the registry with Torskal SAS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 1 dose escalation (3+3 design, sentinel patient with 29-day DLT observation). Single intratumoural injection of TSK-001 (glucose-functionalised gold nanoparticles, 0.3 mg/mL) at 10% of baseline tumour volume (vol/vol) under topical anaesthesia (EMLAPATCH 5%), followed 1 hour later by near-infrared irradiation of the lesion (808 nm, 1 Watt, continuous wave, 10 minutes). Lesion temperature is monitored by infrared thermography. Tumour excision at Day 29 for histology and gold concentration. 3 to 6 patients.
Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. · Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
Phase 1 dose escalation (3+3 design, sentinel patient with 29-day DLT observation). Single intratumoural injection of TSK-001 (glucose-functionalised gold nanoparticles, 0.3 mg/mL) at 15% of baseline tumour volume (vol/vol) under topical anaesthesia (EMLAPATCH 5%), followed 1 hour later by near-infrared irradiation of the lesion (808 nm, 1 W, continuous wave, 10 minutes). Lesion temperature is monitored by infrared thermography. Tumour excision at Day 29 for histology and gold concentration. 3 to 6 patients.
Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. · Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
Phase 1 dose escalation (3+3 design, sentinel patient with 29-day DLT observation). Single intratumoural injection of TSK-001 (glucose-functionalised gold nanoparticles, 0.3 mg/mL) at 20% of baseline tumour volume (vol/vol) under topical anaesthesia (EMLAPATCH 5%), followed 1 hour later by near-infrared irradiation of the lesion (808 nm, 1 W, continuous wave, 10 minutes). Lesion temperature is monitored by infrared thermography. Tumour excision at Day 29 for histology and gold concentration. 3 to 6 patients.
Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. · Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
Phase 1 expansion cohort to identify the recommended Phase 2 dose (RP2D). Two intratumoural injections of TSK-001 at the maximum tolerated dose (MTD) or maximum administered dose (MAD) determined in Part 1, given on Day 1 and Day 15, under topical anaesthesia (EMLAPATCH 5%). Each injection is followed 1 hour later by near-infrared irradiation (808 nm, 1 W, continuous wave, 10 minutes) with infrared monitoring of lesion temperature. Tumour excision at Day 75 for histology and gold concentration. 6 patients, up to 12 if de-escalation is required.
Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. · Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
Phase 2 extension in patients with low-risk nodular BCC in non-operable or surgically complex areas. Two intratumoural injections of TSK-001 at the RP2D identified in Part 2, given on Day 1 and Day 15, under local anaesthesia (lidocaine 1%). Each injection is followed 1 hour later by near-infrared irradiation (808 nm, 1 W, continuous wave, 10 minutes) with infrared monitoring of lesion temperature. Complete response assessed per RECIST v1.1 at Day 29. Excision at investigator discretion between Day 29 and Day 180, or punch biopsy at Day 180. Scar assessment with SBSES and POSAS. Up to 42 patients.
Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. · Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
Investigational class III medical device: sterile, ready-to-use dispersion of glucose-coated plasmonic gold nanoparticles (0.3 mg/mL) in water for injection, without excipients, supplied in 2 mL glass vials. Administered by slow intratumoural injection (20G needle, 0.5 or 1 mL precision syringe; microinjections to avoid pocketing). The injected volume is proportional to baseline tumour volume measured by digital calliper (length × width × depth): 10%, 15% or 20% vol/vol in Part 1, MTD/MAD in Part 2, RP2D in Part 3. Single injection on Day 1 (Part 1) or two injections on Day 1 and Day 15 (Parts 2 and 3). The nanoparticles are biologically inert until activated by 808 nm near-infrared light, which they convert into localised heat.
Commercially available class IIb diode laser (Hyper Diode 808, Hyper Photonics S.r.l., Italy), used outside its labelled indications as the activation source for TSK-001. One hour after each TSK-001 injection, the target lesion is irradiated at 808 nm, 1 Watt, continuous wave, for 10 minutes. These settings are well below those used in routine dermatological applications (12-25 W) and are non-ablative in the absence of TSK-001. Lesion temperature is monitored by infrared thermography, with a target therapeutic window of 42-45 °C; a lesion temperature above 45 °C is a protocol stopping rule.
P1. Number of Participants With Treatment-Emergent Adverse Events (Parts 1 and 2)
Description : Number of participants with at least one treatment-emergent adverse event (TEAE). Severity is graded per CTCAE v5.0 and relationship to TSK-001 and/or NIR irradiation is assessed by the investigator. Results will be reported overall, by maximum severity grade and by relationship category. Unit : participants
Time frame: Day 1 (D1) to Day 180
P2. Number of Participants With Clinically Significant Laboratory Abnormalities (Parts 1 and 2)
Description : Number of participants with at least one post-baseline haematology or clinical chemistry value judged clinically significant by the investigator. Unit : participants
Time frame: from baseline to Day 180
P3. Number of Participants With Clinically Significant Vital Sign Abnormalities (Parts 1 and 2)
Description : Number of participants with at least one post-baseline vital sign value (blood pressure, heart rate, body temperature, respiratory rate) judged clinically significant by the investigator. Unit : participants
Time frame: baseline to Day 360
P4. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Parts 1 and 2)
Description : Number of participants with at least one post-baseline 12-lead ECG finding judged clinically significant by the investigator. Unit : participants
Time frame: baseline to Day 360
P5. Maximum Local Skin Response (LSR) Composite Score (Parts 1 and 2)
Description : The LSR Grading Scale rates 6 signs at the treated site (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration), each from 0 (absent) to 4 (severe). The composite score is the sum of the 6 grades (range 0-24; higher scores indicate more severe reactions). The highest composite score recorded for each participant over the time frame will be reported. Unit : score on a scale
Time frame: Day 1 to Day 360
P6. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Parts 1 and 2)
Description : Number of participants with hypopigmentation, hyperpigmentation or scarring at the treated site, as assessed by the investigator. Unit : participants
Time frame: Day 1 to Day 360
P7. Maximum Pain Intensity on a Visual Analogue Scale (Parts 1 and 2)
Description : Pain at the treated site is self-rated by the participant on a 100 mm VAS (0 mm = no pain, 100 mm = worst imaginable pain). The highest score recorded for each participant will be reported. Unit : mm
Time frame: Day 1 to Day 360
P8. Maximum Lesion Temperature During NIR Irradiation (Parts 1 and 2)
Description : Highest lesion surface temperature measured by infrared thermography during the irradiation session(s). For participants treated twice (Part 2), the highest value across both sessions will be reported. Unit : °C
Time frame: during irradiation on Day 1 (and Day 15 in Part 2)
P9. Percentage of Participants With Complete Response (Part 3)
Description : Complete response is defined as disappearance of the target lesion according to RECIST v1.1, measured with digital callipers. Unit : percentage of participants
Time frame: Day 29
P10. Percentage of Participants With No Residual Tumour on Histology (Part 3)
Description : Absence of residual viable tumour cells on histology of the excised lesion, or of a punch biopsy if no excision is performed. Unit : percentage of participants
Time frame: At excision (Day 29 to Day 180) or Day 180
S1. Maximum Plasma Gold Concentration (Cmax) (Parts 1 and 2)
Description : Cmax of gold in plasma after the first TSK-001 injection, in the PK subset (3 participants per Part 1 cohort and 3 in Part 2). Unit : ng/mL
Time frame: Before injection, 60 min and 24 h after the first injection
S2. Time to Maximum Plasma Gold Concentration (Tmax) (Parts 1 and 2)
Description : Tmax after the first TSK-001 injection, in the PK subset. Unit : hours
Time frame: Before injection, 60 min and 24 h after the first injection
S3. Area Under the Plasma Gold Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) (Parts 1 and 2)
Description : AUC0-24h calculated by non-compartmental analysis, in the PK subset. Unit : ng·h/mL
Time frame: Before injection, 60 min and 24 h after the first injection
S4. Amount of Gold Excreted in Urine (Parts 1 and 2)
Description : Amount of gold excreted in urine over each collection interval, in the PK subset. Unit : µg
Time frame: 0-24 h and 24-48 h after the first injection
S5. Gold Concentration in Tumour Tissue (All Parts)
Description : Gold concentration in tumour tissue measured by ICP-MS, from the punch biopsy and from the excised lesion. Unit : µg/g of tissue
Time frame: Day 1 (60 min after injection) and at excision (Day 29 in Part 1, Day 75 in Part 2, Day 29 to Day 180 in Part 3)
S6. Percentage of Participants With Complete Response (Parts 1 and 2)
Description : Disappearance of the target lesion according to RECIST v1.1. Unit : percentage of participants
Time frame: Day 29
S7. Percentage of Participants With Complete Clinical and Dermoscopic Clearance (All Parts)
Description : A participant is counted as cleared only if both conditions are met: no clinically visible tumour on standardised photography AND no BCC diagnostic structures on dermoscopy. Unit : percentage of participants
Time frame: Day 29
S8. Percentage of Participants With Histological Clearance (Parts 1 and 2)
Description : No residual viable tumour cells on histology of the excised lesion (punch biopsy for non-operable or surgically complex areas). Unit : percentage of participants
Time frame: Day 29 (Part 1) and Day 75 (Part 2)
S9. Stony Brook Scar Evaluation Scale (SBSES) Total Score (Part 3)
Description : Investigator-rated scar assessment, total score ranging from 0 (worst) to 5 (best). Unit : score on a scale
Time frame: Days 15, 29, 43, 90 and 180
S10. Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale Total Score (Part 3)
Description : Six items each rated 1-10. The total score ranges from 6 to 60; higher scores indicate worse scar quality. Unit : score on a scale
Time frame: Days 15, 29, 43, 90 and 180
S11. POSAS - Observer Scale Total Score (Part 3)
Description : Six items each rated 1-10. The total score ranges from 6 to 60; higher scores indicate worse scar quality. Unit : score on a scale
Time frame: Days 15, 29, 43, 90 and 180
S12. Number of Participants With Treatment-Emergent Adverse Events (Part 3)
Description : Number of participants with at least one treatment-emergent adverse event (TEAE). Severity is graded per CTCAE v5.0 and relationship to TSK-001 and/or NIR irradiation is assessed by the investigator. Results will be reported overall, by maximum severity grade and by relationship category. Unit : participants
Time frame: Day 1 to Day 360
S13. Number of Participants With Clinically Significant Laboratory Abnormalities (Part 3)
Description : Number of participants with at least one post-baseline haematology or clinical chemistry value judged clinically significant by the investigator. Unit : participants
Time frame: Baseline to Day 360
S14. Number of Participants With Clinically Significant Vital Sign Abnormalities (Part 3)
Description : Number of participants with at least one post-baseline vital sign value (blood pressure, heart rate, body temperature, respiratory rate) judged clinically significant by the investigator. Unit : participants
Time frame: baseline to Day 360
S15. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Part 3)
Description : Number of participants with at least one post-baseline 12-lead ECG finding judged clinically significant by the investigator. Unit : participants
Time frame: Baseline to Day 360
S16. Maximum Local Skin Response (LSR) Composite Score (Part 3)
Description : The LSR Grading Scale rates 6 signs at the treated site (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration), each from 0 (absent) to 4 (severe). The composite score is the sum of the 6 grades (range 0-24; higher scores indicate more severe reactions). The highest composite score recorded for each participant over the time frame will be reported. Unit : score on a scale
Time frame: Day 1 to Day 360
S17. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Part 3)
Description : Number of participants with hypopigmentation, hyperpigmentation or scarring at the treated site, as assessed by the investigator. Unit : participants
Time frame: Day 1 to Day 360
S18. Maximum Pain Intensity on a Visual Analogue Scale (Part 3)
Description : Pain at the treated site is self-rated by the participant on a 100 mm VAS (0 mm = no pain, 100 mm = worst imaginable pain). The highest score recorded for each participant will be reported. Unit : mm
Time frame: Day 1 to Day 360
S19. Maximum Lesion Temperature During NIR Irradiation (Part 3)
Description : Highest lesion surface temperature measured by infrared thermography during the irradiation session(s). For participants treated twice (Part 3), the highest value across both sessions will be reported. Unit : °C
Time frame: During irradiation on Day 1 and Day 15
Plan to share: No — Individual participant data will not be shared. This is a small first-in-human study (up to 78 participants) that includes standardised clinical photographs of skin lesions, some on the face, which carry a high risk of re-identification even after pseudonymisation. Data are processed under the EU General Data Protection Regulation, and the informed consent does not cover sharing of individual data with third parties. Aggregate results will be made publicly available through the EU medical device database (EUDAMED) in accordance with Regulation (EU) 2017/745, posted on this registry, and submitted for publication in a peer-reviewed journal.
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
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