Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

OptiSkin Medical

Status and phase: Unknown; Phase 4

Conditions: Psoriatic Nail; Psoriasis; Psoriatic Arthritis

Treatments: Drug: Etanercept; Device: OCT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05135312

OPTI-004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Etanercept

Other group

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.

Treatment:

Device: OCT

Drug: Etanercept