check_circleStudy Completed

Dermatitis, Atopic

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

All

Age

18 - 65 Years

Trial summary

Enrollment Goal
42
Trial Dates
September 2018 - October 2018
Phase
N/A
Could I Receive a placebo
No
Products
BAY987534
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
proDermHamburg, 22869, Germany

Primary Outcome

  • AUC of the skin hydration assessed of treatment with the test product compared to untreated
    AUC: Area under the curve
    date_rangeTime Frame:
    Up to 4 weeks

Secondary Outcome

  • AUC of the short term skin hydration
    Comparison of the test product to untreated
    date_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 Baseline
    date_rangeTime Frame:
    Up to 4 weeks
  • Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)
    a.u.: arbitrary units
    date_rangeTime Frame:
    Up to 4 weeks
  • Skin pH
    Comparison of the test product to untreated based on the differences to Baseline
    date_rangeTime Frame:
    Up to 4 weeks
  • Transepidermal water loss
    Comparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skin
    date_rangeTime Frame:
    Up to 4 weeks
  • Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)
    Comparison of the test product to untreated
    date_rangeTime Frame:
    Up to 8 hours
  • Water gradient within stratum corneum assessed by Raman Spectrometry
    Comparison of the test product to untreated
    date_rangeTime Frame:
    Up to 8 hours
  • Number of participants with adverse events (AEs)
    date_rangeTime Frame:
    Up to 4 weeks
  • Compliance check
    The diaries will be collected and checked for compliance and completeness of the daily record
    date_rangeTime Frame:
    Day 29
  • Water content within stratum corneum assessed by Raman Spectrometry (unit: %)
    Comparison of the test product to untreated
    date_rangeTime Frame:
    Up to 8 hours

Trial design

Randomized, controlled, observer-blinded, intra-individual clinical trial to examine the efficacy and safety of a new medical device (modified Diprobase formulation) in adults with quiescent Atopic Dermatitis
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2