Psoriasis Clinical Trial
Official title:
Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography
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).
Status | Recruiting |
Enrollment | 10 |
Est. completion date | August 8, 2022 |
Est. primary completion date | August 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Moderate to severe psoriasis - Psoriasis affecting the fingernails Exclusion Criteria: - Previous treatment with EnbrelĀ® (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 |
Country | Name | City | State |
---|---|---|---|
United States | OptiSkin Medical | New York | New York |
Lead Sponsor | Collaborator |
---|---|
OptiSkin Medical | Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | OCT (clinical) | Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity. | Baseline to 24 weeks | |
Secondary | 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 | |
Secondary | Dermoscopy | Dermoscopy allows for the examination of the skin using skin surface microscopy. | Baseline to 24 weeks |
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