Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

Phase 4

• Conditions: Psoriasis; Psoriatic Arthritis; Psoriatic Nail
• Interventions: Drug: Etanercept; Device: OCT

• Registration Number: NCT05135312
• Lead Sponsor: OptiSkin Medical

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).

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 Timeline

• Study Start: 2021-08-09
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-08-08
• Study Completion: 2022-08-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etanercept	OCT	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.
Etanercept	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.

Primary Outcome Measures

Name	Time	Method
OCT (clinical)	Baseline to 24 weeks	Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

OptiSkin Medical; 🇺🇸 New York, New York, United States