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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002365-34 | EudraCT Number |
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The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild to moderate plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-3073 | Experimental | P-3073 |
|
| vehicle of P-3073 | Placebo Comparator | vehicle of P-3073 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-3073 | Drug |
| ||
| Vehicle of P-3073 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total Nail Psoriasis Severity Index (NAPSI) | Baseline - Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NAPSI matrix | Baseline - Week 24 | |
| Change in NAPSI bed | Week 24 | |
| Nail Physician Global Assessment (PGA) response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Caserini, MD | Polichem S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Bulgaria | |||||
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|
| Week 24 |
| Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI) | Baseline - Week 24 |
| Change in discomfort by means of the Visual Analogue Scale (VAS) | Week 24 |
| Proportions of nails with improvement in total NAPSI | Week 24 |
| Proportions of nails with improvement in NAPSI Matrix | Week 24 |
| Proportions of nails with improvement in NAPSI bed | Week 24 |
| Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. | Week 24 |
| Multiple Locations |
| Czechia |
| Multiple Locations | Germany |
| Multiple Locations | Greece |
| Multiple Locations | Latvia |
| Multiple Locations | Poland |
| Multiple Locations | Russia |