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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004702-34 | EudraCT Number |
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This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omiganan | Experimental |
| |
| Imiquimod | Experimental |
| |
| Omiganan 1% and Imiquimod | Experimental |
| |
| Omiganan 2.5% and Imiquimod | Experimental |
| |
| Placebo | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omiganan | Drug | Omignan 1%, 2.5% |
| |
| Imiquimod |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation | Erythema grading scale | 6 Days |
| Pharmacodynamic (Biomarkers) | Local biomarker sequencing | Within 2 Weeks |
| Pharmacodynamic (Histology) | Histological parameters assessment | Within 2 Weeks |
| Pharmacodynamic (Immunohistochemistry) | Identification of lymphocytes and lineage cells | Within 2 Weeks |
| Pharmacodynamic (TAP) | Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP) | Within 6 Days |
| pharmacodynamic (LSCI) | Assess cutaneous microcirculation using laster speckle imager | Within 6 Days |
| Pharmacodynamic (Colorimetry) | Colorimetric assessment by erythema grading scale | Within 6 Days |
| Pharmacodynamic (Photography) | Photographs of treatment sites will be taken | Within 2 Weeks |
| Pharmacodynamic (Thermography) |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability | Visual Analogue Scale (NRS) pruritus and pain | 2 Weeks |
| Safety (AE) | Adverse Events 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 |
|---|---|
| C000625752 | Omiganan |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Imiquimod 15mg |
|
| Omiganan 1% and Imiquimod | Drug | Omiganan 1% and Imiquimod |
|
| Omiganan 2.5% and Imiquimod | Drug | Omiganan 2.5% and Imiquimod |
|
| Placebo | Drug | Vehicle |
|
Skin temperature measurements will be taken |
| Within 2 Weeks |
| 2 Weeks |
| Safety (Vital Signs) | Vital Signs will be collected throughout the study | 2 Weeks |
| Safety (Laboratory Safety Testing) | Lab samples collected in various timepoints within the study | 2 Weeks |
| Safety (ECG) | ECGs will be collected before beginning and end of study | Within 3 Weeks |
| D006571 | Heterocyclic Compounds |