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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks
30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar® once daily for 4 weeks followed by QOD for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Enstilar | Experimental | once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar 0.005%-0.064% Topical Foam | Drug | Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira |
|
| Measure | Description | Time Frame |
|---|---|---|
| PGA x BSA improvement | body surface area multiplied by physician global assessment | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BSA improvement | body surface area improvement | 16 weeks |
| Dermatology Life Quality Index improvement | patient reported outcome improvements of DLQI (Dermatology Life Quality Index). Calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerry Bagel, MD | Contact | 6094434500 | dreamacres1@aol.com | |
| Elise Nelson | Contact | 6094434500 | enelson@windsordermatology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psoriasis Treatment Center of Central New Jersey | Recruiting | East Windsor | New Jersey | 08520 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2024 | Apr 9, 2024 | 1 |
| 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 |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
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open label
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| 16 weeks |
| Itch Numerical Rating Scale | Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch). | 16 weeks |