Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGOmiganan
Omiganan 1%
DRUGPlacebo
Vehicle
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (Cytokines) | Within 7 Weeks | Cytokine assessment via blood evaluation |
| Pharmacodynamics (Microbiology) | Within 7 Weeks | Microbiology analysis |
| Pharmacodynamics (TEWL) | Within 7 Weeks | Transepidermal water-loss assessment |
| Pharmacodynamics (Thermography) | Within 7 Weeks | Skin temperature measurements will be taken |
| Pharmacodynamics (TAP) | Within 7 Weeks | Analysis of biomarkers captured by Transdermal Analysis Patch |
| Clinical Evaluation (oSCORAD) | Within 7 Weeks | oSCORAD Assessment |
| Clinical Evaluation (EASI) | Within 7 Weeks | EASI Assessment |
| Clinical Evaluation (IGA) | Within 7 Weeks | IGA Assessment |
| Patient-Orientated Outcome Measure (POEM) | Within 7 Weeks | Patient Assessment by collecting POEM |
| Dermatology Life Quality Index (DLQI) | Within 7 Weeks | Assessment of health-related quality of life by measuring DLQI |
| eDiary | Within 4 Weeks | Singe-Question assessment of pruritus and sleeplessness |
| Clinical Photography | Within 7 Weeks | Whole body photograph for qualitative and observational record |
| Pharmacodynamics (Biomarkers) | Within 7 Weeks | Local biomarkers sequencing |
| Pharmacodynamics (Microbiome) | Within 7 Weeks | Microbiome analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Safety (AE) | Within 7 Weeks | Adverse Events will be collected throughout the study |
Countries
Netherlands
Outcome results
None listed