Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

December 16, 2021 updated by: Orit Markowitz MD, OptiSkin Medical

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Drug: Etanercept
TNF-alpha inhibitors improve nail psoriasis.
Other Names:
  • Enbrel
Device: OCT
Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.
Other Names:
  • Optical Coherence Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NAPSI
Time Frame: 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.
Baseline to 24 weeks
OCT (clinical)
Time Frame: Baseline to 24 weeks
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT (sub-clinical)
Time Frame: Baseline to 24 weeks
Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails.
Baseline to 24 weeks
Dermoscopy
Time Frame: Baseline to 24 weeks
Dermoscopy allows for the examination of the skin using skin surface microscopy.
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OptiSkin Medical

Collaborators

Amgen

Investigators

  • Principal Investigator: Orit Markowitz, MD, OptiSkin Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Anticipated)

August 8, 2022

Study Completion (Anticipated)

August 8, 2022

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTI-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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