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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000186-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Sciderm GmbH | INDUSTRY |
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The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS 41004, variant 1, once daily | Experimental | variant 1, once daily |
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| LAS41004, variant 2, once daily | Experimental | variant 2, once daily |
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| LAS41004, variant 3, once daily | Experimental | variant 3, once daily |
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| LAS41004, variant 4, once daily | Experimental | variant 4, once daily |
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| LAS41004, variant 5, once daily | Experimental | variant 5, once daily |
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| LAS41004, variant 6, once daily | Experimental | variant 6, once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41004 | Drug | once daily, topical, 100 microgram |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in thickness of infiltration | measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15) | Day 1 (baseline) vs day 15 day (final) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical score | scoring of total symptom score (0 - 12)will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) | day 1 (baseline) vs day 15 (final) |
| Change in erythema score |
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Key Inclusion Criteria:
oPsoriatic plaques must be located on the trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Willers, MD | Almirall Hermal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Mahlow | Germany |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| C537948 | Ceroid lipofuscinosis, neuronal 1, infantile |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| reference |
| Placebo Comparator |
once daily, 100microgram |
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| reference, once daily | Active Comparator | once daily |
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| reference | Drug | once daily, 100 microgram |
|
scoring of erythema (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
| day1 (baseline) vs day 15 (final) |
| Change in Induration score | scoring of induration (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) | day 1 (baseline) vs day 15 (final) |
| Change in Scaling score | scoring of scaling (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) | day 1 (baseline) vs day 15 (final) |