This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .
proDerm
Hamburg, Germany
AUC of the skin hydration assessed of treatment with the test product compared to untreated
AUC: Area under the curve
Time frame: Up to 4 weeks
AUC of the short term skin hydration
Comparison of the test product to untreated
Time 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
Time frame: Up to 4 weeks
Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)
a.u.: arbitrary units
Time frame: Up to 4 weeks
Skin pH
Comparison of the test product to untreated based on the differences to Baseline
Time 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
Time frame: Up to 4 weeks
Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)
Comparison of the test product to untreated
Time frame: Up to 8 hours
Water gradient within stratum corneum assessed by Raman Spectrometry
Comparison of the test product to untreated
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Time frame: Up to 8 hours
Number of participants with adverse events (AEs)
Time frame: Up to 4 weeks
Compliance check
The diaries will be collected and checked for compliance and completeness of the daily record
Time frame: Day 29
Water content within stratum corneum assessed by Raman Spectrometry (unit: %)
Comparison of the test product to untreated
Time frame: Up to 8 hours