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This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHE-105 Shampoo | Experimental | UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks |
|
| Vehicle Shampoo | Placebo Comparator | Vehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHE-105 | Drug | Topical shampoo containing active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) Treatment Success | The percentage of subjects classified as IGA treatment success | Day 15 |
| Investigator's Global Assessment (IGA) Treatment Success | The percentage of subjects classified as IGA treatment success | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success | Percentage of subjects classified as treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) | Days 8, 15, and 29 |
| Change in Percentage of scalp affected by psoriasis |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Tony Andrasfay | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 01 | San Diego | California | 92123 | United States | ||
| 02 |
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| Vehicle |
| Drug |
Topical shampoo containing no active drug |
|
Change from baseline in the percentage of scalp affected by psoriasis |
| Days 8, 15, and 29 |
| Percentage of subjects with pruritus severity score treatment success | Percentage of subjects classified as treatment success for change from baseline in pruritus severity score using an 11-point numeric rating scale (0-10) | Days 8, 15, and 29 |
| High Point |
| North Carolina |
| 27262 |
| United States |