This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
LUMC/Centre for Human Drug Research
Leiden, Netherlands
Clinical Evaluation (oSCORAD)
oSCORAD Assessment
Time frame: Within 7 Weeks
Clinical Evaluation (EASI)
EASI Assessment
Time frame: Within 7 Weeks
Clinical Evaluation (IGA)
IGA Assessment
Time frame: Within 7 Weeks
Patient-Orientated Outcome Measure (POEM)
Patient Assessment by collecting POEM
Time frame: Within 7 Weeks
Dermatology Life Quality Index (DLQI)
Assessment of health-related quality of life by measuring DLQI
Time frame: Within 7 Weeks
eDiary
Singe-Question assessment of pruritus and sleeplessness
Time frame: Within 4 Weeks
Clinical Photography
Whole body photograph for qualitative and observational record
Time frame: Within 7 Weeks
Pharmacodynamics (Biomarkers)
Local biomarkers sequencing
Time frame: Within 7 Weeks
Pharmacodynamics (Microbiome)
Microbiome analysis
Time frame: Within 7 Weeks
Pharmacodynamics (Microbiology)
Microbiology analysis
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Vehicle
Time frame: Within 7 Weeks
Pharmacodynamics (TEWL)
Transepidermal water-loss assessment
Time frame: Within 7 Weeks
Pharmacodynamics (Thermography)
Skin temperature measurements will be taken
Time frame: Within 7 Weeks
Pharmacodynamics (TAP)
Analysis of biomarkers captured by Transdermal Analysis Patch
Time frame: Within 7 Weeks
Pharmacodynamics (Cytokines)
Cytokine assessment via blood evaluation
Time frame: Within 7 Weeks
Safety (AE)
Adverse Events will be collected throughout the study
Time frame: Within 7 Weeks
Safety (Vital Signs)
Vital Signs will be collected throughout the study
Time frame: Within 7 Weeks
Safety (Clinical Laboratory Tests)
Lab samples collected in various timepoints within the study
Time frame: Within 7 Weeks
Safety (ECG)
ECGs collected before beginning and end of study
Time frame: Within 7 Weeks