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Trial · NCT00855595

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryNominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)Baseline and Week 2NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
SecondaryNumber of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)Week 2, 4, 6, 8 and 12
SecondaryNominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)Baseline and Week 4, 6, 8 and 12NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
SecondaryPercent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)Baseline and Week 2, 4, 6, 8 and 12NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
SecondaryPercentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)Baseline and Weeks 2, 4, 6, 8 and 12
SecondaryPercentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)Weeks 2, 4, 6, 8 and 12
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).
SecondaryPercentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)Weeks 2, 4, 6, 8 and 12
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)
SecondaryPercentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2At Week 2IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
SecondaryPercentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4At Week 4IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
SecondaryPercentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6At Week 6IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
SecondaryPercentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8At Week 8IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
SecondaryPercentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12At Week 12IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
SecondaryInvestigator Rating of Overall Improvement at End of Study (Week 12)Week 12
SecondaryPatient Rating of Overall Improvement at End of Study (Week 12)Week 12
SecondaryPatient Opinion of Cosmetic Acceptability at End of Study (Week 12)Week 12
OtherPatient Opinion of Local TolerabilityWeek 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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