Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging
Primary Purpose
Psoriasis, Psoriatic Arthritis, Psoriatic Nail
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Etanercept
OCT
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis Nails, Psoriatic Arthritis, Enbrel, Biologic
Eligibility Criteria
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
Sites / Locations
- OptiSkin MedicalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Etanercept
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
OCT (clinical)
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
Secondary Outcome Measures
OCT (sub-clinical)
Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails.
Dermoscopy
Dermoscopy allows for the examination of the skin using skin surface microscopy.
Full Information
NCT ID
NCT05135312
First Posted
November 17, 2021
Last Updated
December 16, 2021
Sponsor
OptiSkin Medical
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT05135312
Brief Title
Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging
Official Title
Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Anticipated)
Study Completion Date
August 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OptiSkin Medical
Collaborators
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis, Psoriatic Nail
Keywords
Psoriasis Nails, Psoriatic Arthritis, Enbrel, Biologic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Etanercept
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
TNF-alpha inhibitors improve nail psoriasis.
Intervention Type
Device
Intervention Name(s)
OCT
Other Intervention Name(s)
Optical Coherence Tomography
Intervention Description
Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.
Primary Outcome Measure Information:
Title
NAPSI
Description
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.
Time Frame
Baseline to 24 weeks
Title
OCT (clinical)
Description
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
OCT (sub-clinical)
Description
Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails.
Time Frame
Baseline to 24 weeks
Title
Dermoscopy
Description
Dermoscopy allows for the examination of the skin using skin surface microscopy.
Time Frame
Baseline to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moshe Bressler, DO
Phone
2128283120
Email
moshe@optiskinmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Halima Amro, BS
Phone
2128283120
Email
halima@optiskinmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orit Markowitz, MD
Organizational Affiliation
OptiSkin Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
OptiSkin Medical
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Bressler, DO
Phone
212-828-3120
Email
moshe@optiskinmedical.com
First Name & Middle Initial & Last Name & Degree
Halima Amro, BS
Phone
2128283120
Email
halima@optiskinmedical.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.optiskinmedical.com/clinical-trials/psoriatic-nails-study
Description
Study Sign-Up Page
Learn more about this trial
Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging
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