Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

NCT ID: NCT05135312

Last Updated: 2022-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2022-08-08

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Psoriasis Psoriatic Arthritis Psoriatic Nail

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept

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.

Group Type OTHER

Etanercept

Intervention Type DRUG

TNF-alpha inhibitors improve nail psoriasis.

OCT

Intervention Type DEVICE

Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.

Interventions

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Etanercept

TNF-alpha inhibitors improve nail psoriasis.

Intervention Type DRUG

OCT

Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.

Intervention Type DEVICE

Other Intervention Names

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Enbrel Optical Coherence Tomography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

OptiSkin Medical

OTHER

Sponsor Role lead

Responsible Party

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Orit Markowitz MD

Chief Medical Ofiicer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orit Markowitz, MD

Role: PRINCIPAL_INVESTIGATOR

OptiSkin Medical

Locations

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OptiSkin Medical

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Moshe Bressler, DO

Role: CONTACT

2128283120

Halima Amro, BS

Role: CONTACT

2128283120

Facility Contacts

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Moshe Bressler, DO

Role: primary

212-828-3120

Halima Amro, BS

Role: backup

2128283120

Other Identifiers

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OPTI-004

Identifier Type: -

Identifier Source: org_study_id

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