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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022281-27 | EudraCT Number |
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The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS 41004 dosage 1 | Experimental | dosage 1, once daily |
|
| LAS 41004 dosage 2 | Experimental | dosage 2, once daily |
|
| LAS 41004 dosage 3 | Experimental | dosage 3, once daily |
|
| placebo | Placebo Comparator | once daily |
|
| Reference | Active Comparator | once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: LAS 41004 dosage 1 | Drug | dosage 1, once daily |
| |
| 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) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical score | scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) | 15 days |
| Change in erythema score | scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) |
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Inclusion Criteria:
• Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 6 month
Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:
Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere SCIderm GmbH Confidential Almirall Hermal GmbH Study protocol EudraCT No. 2010-022281-27 Protocol No. H553000-1005 Version 1.0 to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study
A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study and the following 4 weeks after the end of study :
Exclusion Criteria:
Treatment Wash out period Topical treatment in the test area Any topical anti-psoriatic drug 2 weeks Systemic treatment Biologics 6 months Any other systemic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters) 3 months Procedures Phototherapy 4 weeks
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Willers, MD, MBA | Almirall Hermal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Sites#1 | Mahlow | Germany |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Experimental: LAS 41004 dosage 2 |
| Drug |
LAS 41004 dosage 2, once daily |
|
| Experimental: LAS 41004 dosage 3 | Drug | dosage 3, once daily |
|
| Placebo Comparator: placebo | Drug | once daily |
|
| Reference | Drug | Active Comparator,once daily |
|
| 15 days |
| Change in Induration score | scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) | 15 days |
| Change in Scaling score | scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15) | 15 days |
| Number of skin reactions per patient as a measure of safety and tolerability | daily scoring will be performed by investigator | 15 days |
| Number of AEs per patients as a measure of safety and tolerability | reporting will be performed by investigator | 15 days |