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Trial · NCT03688971

Registered outcomes24

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

ListOutcomeTime frameDescription
PrimarySeborrheic dermatitis area severity index (SDASI)6 WeeksAssessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
PrimaryInvestigator global assessment (IGA)6 WeeksThis is a 5-point scale ranging from 0=clear to 4=severe.
PrimaryArea of involvement6 WeeksFacial area involvement is estimated as a % of the body surface area (BSA)
PrimaryPatient Reported Outcome (PRO) - eDiary4 WeeksSingle-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch.
PrimaryPRO - 5-D itch scale6 WeeksMultidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
PrimaryPRO - dermatology life quality index (DLQI)6 WeeksAsses health-related quality of life in general dermatology disability index
PrimaryStandardized photography6 WeeksFacial photographs will be taken by a 2D camera (VISIA-CR)
PrimarySebum measurements6 WeeksMeasurement of sebum excretion by Sebumeter
PrimaryTrans Epidermal Water Loss (TEWL)6 WeeksTo assess barrier status of lesional and non-lesional skin.
PrimaryOptical Coherence Tomography (OCT)6 WeeksMeasurement of cutaneous morphology of seborrheic dermatitis
PrimaryLiquid chromatography-mass spectrometry (LC-MS)6 WeeksWill evaluate the changes in lipid composition of stratum corneum (SC).
SecondarySkin microbiota6 Weekscollection of skin culture sample to evaluate skin microbiota
SecondarySkin mycobiota6 Weekscollection of skin culture sample to evaluate skin mycobiota
SecondaryFaecal microbiome4 Weekscollection of faecal samples to evaluate faecal microbiome
SecondaryAdverse events collected throughout the study6 Weeks
SecondaryVital signs performed at screening and end of study6 WeeksEvaluation of systolic and diastolic blood pressure
SecondaryVital signs performed at screening and end of study6 WeeksEvaluation of pulse rate
SecondaryVital signs performed at screening and end of study6 WeeksEvaluation of temperature
Secondary12-Lead ECGs performed at screening and end of study6 WeeksAssessment of heart rate
Secondary12-Lead ECGs performed at screening and end of study6 WeeksAssessment of PR, QRS, QT, QTcB and QTcF

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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