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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003689-26 | EudraCT Number |
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To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLS001 topical gel, 2.5% | Experimental |
| |
| CLS001 topical gel 1% | Experimental |
| |
| Vehicle gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS001 | Drug | topical gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion) | Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion | 42 Days |
| Clinical assessment (Change in patient symptoms over time using pruritis VAS) | Change in patient symptoms over time using pruritis VAS | 42 Days |
| Clinical Assessment (Change in lesion size over time) | Change in lesion size over time | 42 Days |
| Clinical assessment (Change in patient SCORAD scale score over time) | Change in patient SCORAD scale score over time | 42 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment (Adverse events) | Adverse events will be collected throughout the study | 42 days |
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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 |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Zernikedreef 8 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32315497 | Derived | Niemeyer-van der Kolk T, van der Wall H, Hogendoorn GK, Rijneveld R, Luijten S, van Alewijk DCJG, van den Munckhof EHA, de Kam ML, Feiss GL, Prens EP, Burggraaf J, Rissmann R, van Doorn MBA. Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo-Controlled, Phase II Trial. Clin Transl Sci. 2020 Sep;13(5):994-1003. doi: 10.1111/cts.12792. Epub 2020 May 1. |
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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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| Vehicle |
| Drug |
topical gel |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |