The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
Unnamed facility
Münster, North Rhine-Westphalia, Germany
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Time frame: Up to 29 days
Number of subjects with abnormal vital signs
Vital signs consist of blood pressure, heart rate, and body temperature
Time frame: Up to 10 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 10 weeks
Erythema by means of chromametry
Time frame: Up to 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function
Time frame: Up to 29 days
Skin hydration by means of corneometry
Time frame: Up to 29 days
Intensity of pruritus by means of visual analogue scale (VAS)
Time frame: Up to 29 days
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