Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

Psoriasis Clinical Trial

Official title:

Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135312
• Other study ID #: OPTI-004
• Status: Recruiting
• Phase: Phase 4
• Start date: August 9, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: December 2021
• Source: OptiSkin Medical
• Contact: Moshe Bressler, DO
• Phone: 2128283120
• Email: moshe[@]optiskinmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis
• Psoriatic Nail

Intervention

Drug:
• Etanercept
TNF-alpha inhibitors improve nail psoriasis.

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

Locations

Country	Name	City	State
United States	OptiSkin Medical	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
OptiSkin Medical	Amgen

Country where clinical trial is conducted

United States, 

Outcome

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