Trial · NCT05725018
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Endpoint (number of treatment-related and treatment-emergent adverse events (AEs) and serious adverse events (SAEs) | 6 months | The number of treatment-related and treatment-emergent adverse events (TEAEs), treatment-emergent wound adverse events (TEWAEs), and serious adverse events (SAEs), including systemic and wound-specific adverse events. |
| Primary | Safety Endpoint (number of patients and wounds that have an infection or any related adverse event.) | 6 months | The number of patients and wounds that have an infection or any related adverse event (AE). |
| Primary | Safety Endpoint (number of patients and wounds that result in hospitalization (serious adverse event ) | 6 months | The number of patients and wounds that result in hospitalization (SAE). |
| Primary | Safety Endpoint (Incidence of squamous cell carcinoma) | 6 months | The incidence of squamous cell carcinoma (SCC). |
| Primary | Safety Endpoint RCR status | 6 months | Replication-competent retrovirus (RCR) status. |
| Other | Proportion of RDEB wounds with ≥50%, ≥75%, and complete | 6 months | Proportion of RDEB wounds with ≥50%, ≥75%, and complete (i.e., re epithelialization with no drainage or erosion and presence of only minor crusting) healing at Weeks 12 and 24, as determined by direct Investigator assessment. |
| Other | Extent of pain reduction assessed by the Wong-Baker FACES scale | 6 months | Extent of pain reduction assessed by the Wong-Baker FACES scale (for patients ages ≥6 years old) at Weeks 8, 12, and 24. |
| Other | Longitudinal change in scores of Worst Itch Numeric Rating Scale | 6 months | Longitudinal change in scores of Worst Itch Numeric Rating Scale (WI-NRS; for patients ages ≥6 years old) scores assessed at Weeks 8, 12, and 24 |
| Other | Longitudinal change of Zarit Burden Interview Short Form | 6 months | Longitudinal change of Zarit Burden Interview Short Form (ZBI-12) for caregiver scores related to wound care, assessed at Weeks 12 and 24 (for all ages). |
| Other | Change in Quality of Life in Epidermolysis Bullosa | 6 months | Change in Quality of Life in Epidermolysis Bullosa (QOLEB) scores assessed at Week 24 compared with pretreatment Baseline scores (completed by patients ≥11 years old or with guidance for patients 8 to 10 years old). If patient is \<8 years old, QOLEB should be completed by a legal guardian. |
| Other | Change in Caregiver Global Impression of Pain | 6 months | Change in Caregiver Global Impression of Pain (CrGI-Pain) scores assessed at Weeks 8, 12, and 24 compared with pretreatment Baseline (for all ages). |
| Other | Comparison of how non-collagenous region 1 of the collagen VII molecule | 6 months | Comparison of how non-collagenous region 1 of the collagen VII molecule (NC1) status relates to wound healing and safety profile (if applicable). |
| Other | Comparison of how circulating C7 antibody status relates to wound healing and safety profile | 6 months | Comparison of how circulating C7 antibody status relates to wound healing and safety profile (if applicable). |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT05725018/registered