Trial · NCT06013371
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reaching Investigator's Global Assessment (IGA) Success - Seborrheic Dermatitis (SD) | Baseline and Week 8 | IGA success defined as: clear (0) or almost clear (1) and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms. Clear (0) - Complete clear, no signs of SD Almost Clear (1) - Only slight pink color or trace amounts of scaling Mild (2) - Pink to red color, or slight Moderate (3) - Distinct redness or clearly visible scaling Severe (4) - Severe score in erythema or scaling |
| Primary | Percent Change in Lesion Count Papulopustular Rosacea (PPR) | Baseline and Week 8 | Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks |
| Secondary | Change in SD Severity Score at 8 Weeks | Baseline and 8 weeks | Change from baseline in each component and overall SD score (composed of erythema, scaling, and pruritus components) at 8 weeks. Each component scored 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). Total score from 0-12. Higher score indicates more severe symptoms. |
| Secondary | Number of Patients With Treatment Success Via IGA in PPR | Baseline and 8 weeks | IGA success is defined as clear (0) or almost clear (1),and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms. Clear (0) - No inflammatory lesions present, no erythema Almost Clear (1) - Very few, small papules/pustules, very mild erythema present Mild (2) - Few small or large papules/pustules, moderate erythema Moderate (3) - Several small or large papules/pustules, moderate erythema Severe (4) - Numerous small and/or large papules/pustules, severe erythema |
| Secondary | Percent Change in Clinical Erythema - PPR | Baseline and 8 weeks | Percent change from baseline in clinical erythema assessment at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms. Clear (0) -Clear skin with no signs of erythema Almost Clear (1) - Almost clear; slight redness Mild (2) - Mild erythema; definite redness Moderate (3) - Moderate erythema; marked redness Severe (4) - Severe erythema; fiery redness |
| Secondary | Change in Patient Assessment of Erythema - PPR | Baseline and 8 weeks | Change from baseline in patient severity assessment of erythema at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms. Clear (0) - Clear of unwanted redness Almost Clear (1) - Nearly clear of unwanted redness Mild (2) - Somewhat more redness than I prefer Moderate (3) - More redness than I prefer Severe (4) - Completely unacceptable redness |
| Secondary | Change in Lesion Count - PPR | Baseline, 8 weeks, 12 weeks | Change from baseline and from 8 weeks in inflammatory (papule/pustule) lesion count at 12 weeks |
| Secondary | Change in IGA Score - SD and PPR | Baseline and 8 weeks | Change from baseline in IGA score at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms. SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema |
| Secondary | Percent Change in IGA Score - SD and PPR | Baseline and 8 weeks | Percent change from baseline in IGA score at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms. SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema |
| Secondary | Change in IGA Score - SD and PPR | Baseline and Week 12 | Change from baseline in IGA at 12 weeks (i.e., 4 weeks after treatment cessation). Full scale is scored from 0-4, higher score indicates more severe symptoms. SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema |
| Secondary | Change in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 8 | Baseline and Week 8 | Change from baseline in PP-NRS at 8 weeks On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', patient rates their itch at the worst moment during the previous 24 hours. Higher score indicates more severe symptoms. |
| Secondary | Number of Study Drug Related Adverse Events | 12 weeks | Number of adverse events reported throughout the study that are deemed related to study drug. |
| Secondary | Frequency of Study Drug Related Adverse Events | 12 weeks | The frequency at which adverse events that are deemed related to study drug are reported throughout the study. |
| Secondary | Severity of Adverse Events | 12 weeks | Severity will be measured as a category (mild, Moderate, severe) according to CTCAE 5.0. |
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/NCT06013371/registered