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The overall purpose of this study is to support the development of a DLX105 topical formulation for the indication mild to moderate psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| DLX105 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLX105 | Drug | intradermal injections (volume: 0.1 mL) of 0.02 mg (low dose cohort), 1 mg (high dose cohort) DLX105, days: Day 1, Day 4, Day 7 and Day 10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability: Investigator's assessment of local tolerability using a validated score for each treatment area. Patient's assessment of subjective tolerability sensations (burning, itching, pain) recorded on a visual analogue scale (VAS) (0-10 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables: | Adverse events Detection of anti-drug antibodies (ADAs). Assessment of immunogenic potential of DLX105 by ELISA with coated DLX105 to capture anti-DLX105 antibodies | 28 days |
| Efficacy variables |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum | Vienna | Austria | ||||
| Universitätsklinikum Münster (UKM) |
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clinical signs of pharmacodynamic activity to intra-dermal administration of DLX105
| 28 days |
| Münster |
| 48149 |
| Germany |