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Trial · NCT05708677

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryWound Closure5 yearsProportion of RDEB wounds with healing ≥50%, ≥75%, and 100% at all clinic visits up to Month 54 as determined by direct investigator assessment.
PrimaryPain Severity Scale (Wong-Baker FACES)5 yearsChange in pain assessed by Wong-Baker FACES scale at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
PrimaryItch Severity Scale5 yearsLongitudinal change of Itch severity scores assessed at all clinic visits up to Week 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
PrimaryZarit Burden Interview Scale5 years
Longitudinal change of Zarit Burden Interview Short Form (ZBI-12) for caregiver scores related to wound care, assessed at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 4, with the higher scores being the worse outcome.
PrimaryQuality of Life in Epidermolysis Bullosa5 yearsQuality of Life in Epidermolysis Bullosa (QOLEB) responses will be assessed at all clinic visits up to Month 54.
PrimaryCaregiver Global Impression of Change for Pain Scale5 years
Caregiver Global Impression of Change for Pain (CrGI-Pain) scores assessed at all clinic visits up to Month 54. The minimum score value is 1 and the maximum score value is 7, with the higher scores being the worse outcome.
PrimaryWound Infection and Adverse Events5 yearsThe number of participants and wounds that have an infection or any related adverse event.
PrimaryThe number of treatment-emergent adverse events.5 yearsThe number of treatment-emergent adverse events.
PrimarySerious Adverse Events5 yearsThe number of participants and wounds that result in hospitalization (serious adverse event \[SAE\]).
PrimaryIncidence of squamous cell carcinoma.5 yearsIncidence of squamous cell carcinoma.
PrimaryReplication-competent retrovirus (RCR) status5 yearsReplication-competent retrovirus (RCR) status

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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