Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

Recruitment & Eligibility

Inclusion Criteria

Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
Confirmed AD diagnosis;
Symptoms present for at least 1 year;
EASI between 7.1 - 50.0, inclusive at screening;
2-20% body surface area (BSA) affected at screening;
Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
Able to participate and willing to give written informed consent and to comply with the study restrictions;
Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria

Any current and / or recurrent clinical significant skin condition other than AD;
Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

Study & Design

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics (Biomarkers)	Within 7 Weeks	Local biomarkers sequencing
Pharmacodynamics (Microbiome)	Within 7 Weeks	Microbiome analysis
Pharmacodynamics (Microbiology)	Within 7 Weeks	Microbiology analysis
Dermatology Life Quality Index (DLQI)	Within 7 Weeks	Assessment of health-related quality of life by measuring DLQI
Pharmacodynamics (TEWL)	Within 7 Weeks	Transepidermal water-loss assessment
Pharmacodynamics (Thermography)	Within 7 Weeks	Skin temperature measurements will be taken
Pharmacodynamics (Cytokines)	Within 7 Weeks	Cytokine assessment via blood evaluation
Clinical Evaluation (oSCORAD)	Within 7 Weeks	oSCORAD Assessment
Patient-Orientated Outcome Measure (POEM)	Within 7 Weeks	Patient Assessment by collecting POEM
eDiary	Within 4 Weeks	Singe-Question assessment of pruritus and sleeplessness
Clinical Evaluation (EASI)	Within 7 Weeks	EASI Assessment
Clinical Evaluation (IGA)	Within 7 Weeks	IGA Assessment
Clinical Photography	Within 7 Weeks	Whole body photograph for qualitative and observational record
Pharmacodynamics (TAP)	Within 7 Weeks	Analysis of biomarkers captured by Transdermal Analysis Patch

Secondary Outcome Measures

Name	Time	Method
Safety (AE)	Within 7 Weeks	Adverse Events will be collected throughout the study
Safety (Vital Signs)	Within 7 Weeks	Vital Signs will be collected throughout the study
Safety (Clinical Laboratory Tests)	Within 7 Weeks	Lab samples collected in various timepoints within the study
Safety (ECG)	Within 7 Weeks	ECGs collected before beginning and end of study

Recruitment & Eligibility