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Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-118 Lotion | Experimental | 8 Weeks |
|
| HP Monad Lotion | Experimental | 8 Weeks |
|
| Ultravate Cream | Active Comparator | 2 Weeks |
|
| Tazorac Cream | Active Comparator | 4 Weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-118 Lotion | Drug | Lotion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Skin Reactions (LSRs) | Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe. | 8 Weeks |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 12 | Anaheim | California | 92801 | United States | ||
| Valeant Site 05 |
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| HP Monad Lotion |
| Drug |
Lotion |
|
|
| Ultravate Cream | Drug | Cream |
|
|
| Tazorac Cream | Drug | Cream |
|
|
| Encino |
| California |
| 91436 |
| United States |
| Valeant Site 01 | San Diego | California | 92093 | United States |
| Valeant Site 07 | Santa Rosa | California | 95401 | United States |
| Valeant Site 10 | Orange Park | Florida | 32065 | United States |
| Valeant Site 09 | Sanford | Florida | 32771 | United States |
| Valeant Site 08 | Atlanta | Georgia | 30301 | United States |
| Valeant Site 04 | Plainfield | Indiana | 46168 | United States |
| Valeant Site 06 | New York | New York | 10001 | United States |
| Valeant Site 11 | Philadelphia | Pennsylvania | 19019 | United States |
| Valeant Site 03 | Austin | Texas | 73301 | United States |
| Valeant Site 02 | Katy | Texas | 77449 | United States |
| 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 |
|---|---|
| C064466 | halobetasol |
| D000091364 | Transcriptional Coactivator with PDZ-Binding Motif Proteins |
| ID | Term |
|---|---|
| D048868 | Adaptor Proteins, Signal Transducing |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
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