Psoriasis, Psoriatic Arthritis, Psoriatic Nail
Conditions
Keywords
Psoriasis Nails, Psoriatic Arthritis, Enbrel, Biologic
Brief summary
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).
Detailed description
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.
Interventions
DRUGEtanercept
TNF-alpha inhibitors improve nail psoriasis.
DEVICEOCT
Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.
Sponsors
Amgen
OptiSkin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe psoriasis * Psoriasis affecting the fingernails
Exclusion criteria
* Previous treatment with Enbrel® (etanercept) * Active infection * Rheumatoid arthritis * Any personal or family history of any neurologic demyelinating disease * Receipt of investigational drugs or biologics within 4 weeks of the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NAPSI | Baseline to 24 weeks | 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. |
| OCT (clinical) | Baseline to 24 weeks | Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OCT (sub-clinical) | Baseline to 24 weeks | Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails. |
| Dermoscopy | Baseline to 24 weeks | Dermoscopy allows for the examination of the skin using skin surface microscopy. |
Countries
United States
Contacts
Primary ContactMoshe Bressler, DO
Backup ContactHalima Amro, BS
Outcome results
None listed