Trial · NCT04773587
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | Week 4 | The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. |
| Secondary | Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | Week 4 | The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
| Secondary | Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | Week 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). |
| Secondary | Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | Week 2 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). |
| Secondary | Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | Week 1 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). |
| Secondary | Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 | Week 4 | The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. |
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
| Secondary | Achievement of vIGA-AD Success at Week 2 | Week 2 | The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
| Secondary | Achievement of vIGA-AD Success at Week 1 | Week 1 | The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 | Week 1 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
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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GET https://conductscience.org/api/trials/v1/NCT04773587/registered