check_circleStudy Completed
Dermatitis, Atopic
Bayer Identifier:
19689
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Functional study to investigate the efficacy of a new medical device (modified Diprobase formulation)
Trial purpose
This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
Key Participants Requirements
Sex
AllAge
18 - 65 YearsTrial summary
Enrollment Goal
42Trial Dates
September 2018 - October 2018Phase
N/ACould I Receive a placebo
NoProducts
BAY987534Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | proDerm | Hamburg, 22869, Germany |
Primary Outcome
- AUC of the skin hydration assessed of treatment with the test product compared to untreatedAUC: Area under the curvedate_rangeTime Frame:Up to 4 weeks
Secondary Outcome
- AUC of the short term skin hydrationComparison of the test product to untreateddate_rangeTime Frame:Day 1
- Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baselinedate_rangeTime Frame:Up to 4 weeks
- Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)a.u.: arbitrary unitsdate_rangeTime Frame:Up to 4 weeks
- Skin pHComparison of the test product to untreated based on the differences to Baselinedate_rangeTime Frame:Up to 4 weeks
- Transepidermal water lossComparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skindate_rangeTime Frame:Up to 4 weeks
- Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)Comparison of the test product to untreateddate_rangeTime Frame:Up to 8 hours
- Water gradient within stratum corneum assessed by Raman SpectrometryComparison of the test product to untreateddate_rangeTime Frame:Up to 8 hours
- Number of participants with adverse events (AEs)date_rangeTime Frame:Up to 4 weeks
- Compliance checkThe diaries will be collected and checked for compliance and completeness of the daily recorddate_rangeTime Frame:Day 29
- Water content within stratum corneum assessed by Raman Spectrometry (unit: %)Comparison of the test product to untreateddate_rangeTime Frame:Up to 8 hours
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2