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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003849-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omiganan 1% | Experimental |
| |
| Omiganan 1.75% | Experimental |
| |
| Omiganan 2.5% | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omiganan | Drug | Omiganan 1% |
| |
| Omiganan |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation (oSCORAD) | oSCORAD Assessment | Within 7 Weeks |
| Clinical Evaluation (EASI) | EASI Assessment | Within 7 Weeks |
| Clinical Evaluation (IGA) | IGA Assessment | Within 7 Weeks |
| Patient-Orientated Outcome Measure (POEM) | Patient Assessment by collecting POEM | Within 7 Weeks |
| Dermatology Life Quality Index (DLQI) | Assessment of health-related quality of life by measuring DLQI | Within 7 Weeks |
| eDiary | Singe-Question assessment of pruritus and sleeplessness | Within 4 Weeks |
| Clinical Photography | Whole body photograph for qualitative and observational record | Within 7 Weeks |
| Pharmacodynamics (Biomarkers) | Local biomarkers sequencing | Within 7 Weeks |
| Pharmacodynamics (Microbiome) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (AE) | Adverse Events will be collected throughout the study | Within 7 Weeks |
| Safety (Vital Signs) | Vital Signs will be collected throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. (Koos) Burggraaf, MD, PhD | Centre for Human Drug Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LUMC/Centre for Human Drug Research | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C000625752 | Omiganan |
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| Drug |
Omiganan 1.75% |
|
| Omiganan | Drug | Omiganan 2.5% |
|
| Placebo | Drug | Vehicle |
|
Microbiome analysis
| Within 7 Weeks |
| Pharmacodynamics (Microbiology) | Microbiology analysis | Within 7 Weeks |
| Pharmacodynamics (TEWL) | Transepidermal water-loss assessment | Within 7 Weeks |
| Pharmacodynamics (Thermography) | Skin temperature measurements will be taken | Within 7 Weeks |
| Pharmacodynamics (TAP) | Analysis of biomarkers captured by Transdermal Analysis Patch | Within 7 Weeks |
| Pharmacodynamics (Cytokines) | Cytokine assessment via blood evaluation | Within 7 Weeks |
| Within 7 Weeks |
| Safety (Clinical Laboratory Tests) | Lab samples collected in various timepoints within the study | Within 7 Weeks |
| Safety (ECG) | ECGs collected before beginning and end of study | Within 7 Weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |