Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

Sponsor

OptiSkin Medical (Other)

Overall Status

Recruiting

CT.gov ID

NCT05135312

Collaborator

Amgen (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Psoriatic Arthritis Psoriatic Nail	Drug: Etanercept Device: OCT	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 9, 2021

Anticipated Primary Completion Date :

Aug 8, 2022

Anticipated Study Completion Date :

Aug 8, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

NAPSI [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.
OCT (clinical) [Baseline to 24 weeks]
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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