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Trial · NCT07891949

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryS11. POSAS - Observer Scale Total Score (Part 3)Days 15, 29, 43, 90 and 180Description : 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
SecondaryS12. Number of Participants With Treatment-Emergent Adverse Events (Part 3)Day 1 to Day 360
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
SecondaryS13. Number of Participants With Clinically Significant Laboratory Abnormalities (Part 3)Baseline to Day 360Description : Number of participants with at least one post-baseline haematology or clinical chemistry value judged clinically significant by the investigator. Unit : participants
SecondaryS14. Number of Participants With Clinically Significant Vital Sign Abnormalities (Part 3)baseline to Day 360
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
SecondaryS15. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Part 3)Baseline to Day 360Description : Number of participants with at least one post-baseline 12-lead ECG finding judged clinically significant by the investigator. Unit : participants
SecondaryS16. Maximum Local Skin Response (LSR) Composite Score (Part 3)Day 1 to Day 360
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
SecondaryS17. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Part 3)Day 1 to Day 360Description : Number of participants with hypopigmentation, hyperpigmentation or scarring at the treated site, as assessed by the investigator. Unit : participants
SecondaryS18. Maximum Pain Intensity on a Visual Analogue Scale (Part 3)Day 1 to Day 360
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
SecondaryS19. Maximum Lesion Temperature During NIR Irradiation (Part 3)During irradiation on Day 1 and Day 15
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

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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