Trial · NCT06563323
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Healing | Week 32 | Defined as the proportion of patients with complete re-epithelization, defined as a100% re-epithelialization without any drainage of the target ulcer at week 32. |
| Secondary | Physician Global Assessment (PGA) | Week 32 | Assessing the proportion of patients that show target ulcer healing in response to study treatment as measured by achieving PGA between 0 and 1 after treatment with guselkumab at week 32. This scale has been used in previous trials: 0 = total resolution of target ulcer with no signs of active PG 1= almost completely healed target ulcer with only minimal signs of active PG 2 = evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3 = evidence of target ulcer healing which involves less than 50% of ulcer/margin 4 = no evidence of target healing ulcer |
| Secondary | Decrease in ulcer area size long-term | Week 32 | The proportion of patients with decrease in ulcer area size of at least 50% after treatment at week 32 |
| Secondary | Decrease in ulcer area size short-term | Week 16 | The proportion of patients with decrease in ulcer area size of at least 50% after treatment at Week 16 |
| Secondary | Mean decrease in ulcer area size short-term | Week 16 | Mean decrease in ulcer area size from Week 0 to Week 16 |
| Secondary | Mean decrease in ulcer area size long-term | Week 32 | Mean decrease in ulcer area size from Week 0 to Week 32 |
| Secondary | Skindex Mini | Week 32 | The Skindex Mini is a 3-item questionnaire, assessing symptom, emotion, and function related to skin disease. We will measure the mean change in Skindex Mini score from Week 0 to Week-32 will be reported with two-sided 95% confidence interval. Change in Skindex Mini score will be analyzed using a paired t-test with 0.05 significance level. Generalized estimating equation (GEE) methods will be further used to characterize changes in Skindex Mini score (max = 5, min = 0) over time. Higher scores indicated worsened quality of life due to skin disease. |
| Secondary | Skin pain scale improvement over 7 days | Week 0 to 32 | The proportion of participants achieving a minimum of a 2 point decrease in the NRS at Week 0 and Week 32 The pain NRS is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable" in the last 7 days. |
| Secondary | Skin pain scale improvement over 24 hours | Week 0 to 32 | The proportion of participants achieving an improvement in reported peak pain Numeric Rating Scale (NRS) assessment at Week 0 and Week 32. The peak pain NRS assessment is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable" in the last 24 hours |
| Secondary | Change in physical function | Week 0 to 32 | The mean change in participant physical function from Week 0 to Week 32. Physical function is a subject-administered 5 category scale that assesses the impact of PG on participant physical function from "with no difficulty" to "can't do because of ulcer". |
| Secondary | Mean change in global assessment score | Week 0 to 32 | The mean change in participant global assessment from Week 0 to Week 32. The participant global assessment is a subject administered 5 category scale (ranging from "clear" to "severe" that measures participant perspective of the status of their skin disease. |
| Secondary | Target ulcer remains healed | Week 40 | The proportion of participants with target ulcer that remains healed by Week 40 |
| Secondary | Time to recurrence | Week 40 | Time to recurrence defined as the duration of time from documented target lesion healing and further episodes of PG at any site. |
| Secondary | Treatment failure | Week 32 | The number of participants experiencing treatment failure. |
| Other | Evaluation of cytokine gene expression | Week 0 and Week 32 | Cytokine gene expression before and after treatment in skin, wound fluid, saliva and blood samples measured by enzyme-linked immunosorbent assay (ELISA) |
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/NCT06563323/registered