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Trial · NCT04419259

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEffect of erenumab on days of flushing12 weeks
Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 12. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)
SecondaryEffect of erenumab on erythema12 weeksMean change in erythema from Baseline to week 4, 8 and 12. Will be evaluated by Clinicians Erythema Assessment (CEA)
SecondaryEffect of erenumab on quality of life: Dermatology Life Quality Index (DLQI)12 weeksMean change in quality of life from Baseline to week 4, 8 and 12. Will be evaluated by Dermatology Life Quality Index (DLQI)
SecondaryProportion of patients that reach a 50% reduction in number of days with flushing12 weeks
To evaluate the proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)
SecondaryEffect of erenumab on days of flushing8 weeks
Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 4 and 8. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)
SecondaryEffect of erenumab on depression12 weeksMean change in depressive symptoms from Baseline to week 4, 8 and 12. Evaluated by Hospital Anxiety and Depression Scale (HADS).
SecondaryEffect of erenumab on overall rosacea symptoms12 weeksProportion of patients with Investigator's Global Assessment (IGA) '0' or '1' with an at least 2-point reduction from baseline to week 4, 8 and 12.
SecondaryEffect of erenumab on inflammatory lesions12 weeksMean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12
SecondaryProportion of patients that reach a 50% reduction in self-assessed rosacea symptoms12 weeksProportion of patients with at least 50% reduction in number of days with Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.
SecondaryEffect of erenumab on self-assessed rosacea symptoms12 weeksMean change in Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.
SecondaryEffect of erenumab on depressive symptoms12 weeksMean change in Quicky Inventory Depressive Symptomatology (QIDS) from Baseline to week 4, 8 and 12
SecondaryEffect of erenumab on overall rosacea severity12 weeksMean change in overall rosacea severity from Baseline to week 4, 8 and 12. Evaluated by Rosacea Area and Severity Index (RASI)
SecondaryEffect of erenumab on rosacea symptoms12 weeksMean change in rosacea symptoms from Baseline to week 4, 8 and 12. Evaluated by Rosacea Clinical Scorecard (RCS)
SecondaryEffect of erenumab on rosacea-specific quality of life: Rosacea-specific Quality-of-Life index (RosaQoL)12 weeksMean change in rosacea-specific quality of life from Baseline to week 4, 8 and 12. Evaluated by the Rosacea-specific Quality-of-Life index (RosaQoL)
OtherTolerability of erenumab in patients with rosacea12 weeksTo evaluate the tolerability of erenumab in patient with rosacea through assessment of adverse events at every visit from Baseline to week 4, 8 and 12.

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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