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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001384-45 | EudraCT Number |
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| Name | Class |
|---|---|
| proDERM GmbH | INDUSTRY |
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The aim of the exploratory study is to compare dose related effects of LAS41004 formulations in a non-occlusive PPT.
Going for a non-occlusive application design will allow to draw practical conclusions as being similar to a real treatment situation (compared with a occluded design to maximise effects)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| variant1 | Experimental | topical ointment, once daily application |
|
| variant 2 | Experimental | topical ointment, once daily application |
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| variant 3 | Experimental | topical ointment, once daily application |
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| variant4 | Experimental | topical ointment, once daily application |
|
| variant 5 | Experimental | topical ointment, once daily application |
|
| variant 6 | Placebo Comparator | topical ointment, once daily application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41004 | Drug | once daily, topical ointment, 100 microgram per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of skin thickness(AUC, area under the curve) | Measurement of skin thickness will be performed by ultrasound (distance between lower border of entry echo and lower border of dermis). The area under the curve, AUC, from day 1 to day 22 will be compared to the reference formulations. | day 1 to day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in scaling | scoring of scaling (score 0-4) will be performed by investigator | baseline vs day 22 |
| decrease in erythema | scoring of erythema (score 0-4) wil be performed by investigator |
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Inclusion Criteria:
18 to 75 years of age
Caucasian men and women
Suffering from mild to moderate plaque psoriasis of at least 6 months duration that is amenable to local therapy
With at least one stable psoriatic plaque in an area sufficient for product application meeting the following criteria:
In the case of women of childbearing potential, using reliable methods of contraception which result in a low failure rate i.e. less than 1% per year (eg contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner)
Exclusion Criteria:
Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study Retinoids Ciclosporin Methotrexate Fumaric acid esters 3 months prior to study day 1 and during conduct of study Anti-inflammatory substances, NSAIDs 2 weeks prior to study day 1 and during conduct of study Biologics 6 months prior to study day 1 and during conduct of study Planned initiation of, or changes to concomitant medication that could affect Psoriasis (e.g. beta blockers, anti-malaria drugs, lithium) 8 weeks before study start and during study
Skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections Rosacea, perioral dermatitis in test area Moderate or severe illness within the last two weeks before first exposure Other known infectious diseases (e.g. hepatitis or AIDS) Other skin diseases that may confound the evaluation of psoriasis
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Willers, MD | Almirall Hermal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Schenefeld | 22869 | 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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| ID | Term |
|---|---|
| D013256 | Steroids |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| control positive |
| Active Comparator |
topical ointment,once daily application |
|
|
| baseline vs day 22 |
| decrease of induration | scoring of induration (score 0-4) will be performed by investigator | baseline vs day 22 |
| assessment of (s)AE | a daily record will be performed and if needed the severity and causality assessed | from baseline to day 22 |