Trial · NCT06648772
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects achieving IGA treatment success after 8 weeks of treatment | Baseline, week 8 | The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability. Treatment success is defined as an IGA score of 0 or 1 with an improvement of ≥ 2 points from baseline. |
| Secondary | Proportion of subjects achieving PASI-75 after 8 weeks of treatment. | Baseline, Week 8 | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Subjects achieving PASI-75 are those who achieve a 75% reduction in PASI from baseline. |
| Secondary | Proportion of subjects achieving PASI-90 after 8 weeks of treatment. | Baseline, Week 8 | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Subjects achieving PASI-90 are those who achieve a 90% reduction in PASI from baseline. |
| Secondary | Time required to achieve PASI-50 from baseline. | Until week 8 | Time required to achieve PASI-50 (i.e., PASI reduction ≥ 50% from baseline) from baseline. |
| Secondary | Proportion of subjects achieving IGA treatment success after 4 weeks of treatment. | Baseline, Week 4 | The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability. Treatment success is defined as an IGA score of 0 or 1 with an improvement of ≥ 2 points from baseline. |
| Secondary | Proportion of subjects with an I-IGA score ≥ 2 points at baseline achieving an I-IGA score of 0 or 1 and an improvement of ≥ 2 points from baseline after 8 weeks of treatment | Baseline, Week 8 | I-IGA means Intertriginous area IGA. For subjects with intertriginous area involvement of at least 'mild' severity by IGA (I-IGA≥2) at Baseline (using the IGA scale but evaluating intertriginous areas ONLY and NOT whole body involvement), an I-IGA will be recorded. |
| Secondary | Proportion of subjects with an I-IGA score ≥ 2 points at baseline achieving an I-IGA score of "0" after 8 weeks of treatment | Baseline, Week 8 | I-IGA means Intertriginous area IGA. For subjects with intertriginous area involvement of at least 'mild' severity by IGA (I-IGA≥2) at Baseline (using the IGA scale but evaluating intertriginous areas ONLY and NOT whole body involvement), an I-IGA will be recorded. |
| Secondary | Proportion of subjects with WI-NRS of ≥ 4 at baseline and a decrease in WI-NRS of ≥ 4 from baseline after 2, 4, and 8 weeks of treatment | Week 2, 4, 8 | WI-NRS (Worst Itch Numerical Rating Scale) assessments will be performed for subjects 12 years and older. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"). |
| Secondary | Changes from baseline in the score of DLQI (aged ≥ 17 years)/CDLQI (aged 6-16 years) after 4 and 8 weeks of treatment | Week 4, 8 | Dermatology Life Quality Index (DLQI) and Children's Dermatology Life Quality Index (CDLQI) will be performed to measure how much skin problem has affected subjects' life over the last week. |
| Secondary | Changes from baseline in the total score of PSD (for adult subjects only) after 4 and 8 weeks of treatment | From baseline to Week 4 and 8 | Psoriasis Symptom Diary (PSD) will be used to assess the improvement in psoriasis symptom. |
| Secondary | treatment emergence adverse events | Throughout the study | Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death. |
| Secondary | Trough concentration (Ctrough) | week 2, 4, 6, 8 | Trough concentration of plasma roflumilast and its N-oxide |
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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