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Trial · NCT07914088

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryThe change of IGA to 0 or 1 at visit 4 after 14 days treatmentFrom Visit 2 (Day 1) to Visit 4 (Day 15) (14 days treatment)Proportion of subjects with the Investigator's Global Assessment (IGA) score of 0 or 1 at Visit 4 (Day 15).
SecondaryEfficacy - the change of IGAEvaluated at Visit 3 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 29)Proportion of subjects achieving the Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Visit 3 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 29)
SecondaryEfficacy - the change of lesion area(s) (cm²)Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Change from baseline (Visit 2) of lesion area(s) to Visit 3-6
SecondaryEfficacy - the change of pruritus NRSEvaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Change from baseline (Visit 2) in pruritus NRS(Numerical Rating Scale) of itch level on lesion area(s) to Visit 3-6
SecondaryEfficacy - the change ≥ 2 points of reduction of pruritus NRSEvaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Proportion of subjects having ≥ 2 points of reduction from baseline (Visit 2) in pruritus NRS for worst itch in the past 24 hours on lesion area(s) to Visit 3-6
SecondaryEfficacy - the change of signs of atopic dermatitisEvaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Change from baseline (Visit 2) in signs of atopic dermatitis (erythema, edema/papulation, excoriation, and lichenification) with grading from 0(none) to 3(severe) on lesion area(s) to Visit 3-6
SecondarySafety- AE and SAEEvaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Incidence of AE and SAE during Visit 2-6 and AE will be categorized by severity (toxicity grade) and relationship to the study intervention
SecondarySafety - change of vital signEvaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Change from baseline (Visit 2) in vital signs to Visit 3-6
SecondarySafety - abnormality in physical examination occurredEvaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Abnormality in physical examination at Visit 2-6
SecondarySafety - ECG resultEvaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Transition of ECG result from normal to abnormal findings from baseline (Visit 2) to Visit 3-6
SecondarySafety - Lab parametersEvaluated at Visit 1 (-14 to -1 Day), (Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Change from baseline (Visit 1) in laboratory parameters to Visit 3-6
SecondarySafety - assessment of local tolerabilityEvaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)Proportion of subjects with scores of 0 and 1 in each symptom of assessment of local tolerability (erythema, edema, vesiculation, and excoriation) with grading from 0 (none) to 3 (severe) at Visit 2-6

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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