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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).
Psoriasis often affects the fingernails, making them yellow, brittle, painful and prone to infections. These symptoms can be difficult to manage, so OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).
OCT is being studied as a way to better diagnosis psoriatic nail disease, monitor response to therapy, and identify changes even before they become apparent, potentially leading to earlier treatment or prevention of future psoriatic arthritis.
Study-related care and medication are provided at no cost, and reimbursement for reasonable local transportation may be available to qualified individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Other | 50mg etanercept subcutaneously twice weekly for 3 months, followed by once weekly for another 3 months for a total duration of 6 months or 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | TNF-alpha inhibitors improve nail psoriasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NAPSI | Nail Psoriasis Severity Index (NAPSI) score is an established measure of nail disease ranging from 0-100. A higher score indicates more severe nails psoriasis. | Baseline to 24 weeks |
| OCT (clinical) | Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity. | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| OCT (sub-clinical) | Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails. | Baseline to 24 weeks |
| Dermoscopy | Dermoscopy allows for the examination of the skin using skin surface microscopy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Bressler, DO | Contact | 2128283120 | moshe@optiskinmedical.com | |
| Halima Amro, BS | Contact | 2128283120 | halima@optiskinmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Orit Markowitz, MD | OptiSkin Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OptiSkin Medical | Recruiting | New York | New York | 10128 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| OCT | Device | Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity. |
|
|
| Baseline to 24 weeks |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |