Trial · NCT04092452
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 25 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | At weeks 1, 2, 4, 6, 8, 12 and 16 | The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed. |
| Secondary | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | At weeks 4, 8, 12 and 16 | The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. |
| Secondary | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | At weeks 4, 8, 12 and 16 | The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined a change from baseline in total score, where negative value means improvement in DLQI. |
| Secondary | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | At weeks 4, 8, 12 and 16 | The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined the percentage of patients with complete resolution of dermatology specific quality of life impact, as assessed by a total score of ≤ 1 (range: 0 - 30), where higher percentage indicates better improvement in DLQI. |
| Secondary | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | At weeks 1, 2, 4, 6, 8, 12 and 16 | In summary statistics for pharmacokinetic, concentration values below the lower limit of quantification (LLOQ) was set to zero. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04092452/registered?page=2