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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003757-22 | EudraCT Number |
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Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS41004 | Experimental | Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily |
|
| control | Active Comparator | Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41004 | Drug |
| ||
| control |
| Measure | Description | Time Frame |
|---|---|---|
| Total symptom score | The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration | day 28 vs baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Total symtom score (during study performance) | Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22 | Days 4, 8, 15, and 22 |
| Physician's global assessment (PGA) | Days 1, 4, 8, 15, 22 and 29 |
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Inclusion Criteria (main):
mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;
Exclusion Criteria (main):
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| Name | Affiliation | Role |
|---|---|---|
| Walter Wigger-Alberti, Dr med | bioskin, Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Hamburg | 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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| Physician's global tolerability assessment (PGTA) | 4, 8, 15, 22 and 29 |