CClinicalTrials.gg
Status unknownNCT05135312Updated Jan 6, 2022

Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

A Phase 4 interventional study of Etanercept and OCT in Psoriasis, Psoriatic Arthritis and Psoriatic Nail, sponsored by OptiSkin Medical. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-06.

Sponsored by OptiSkin Medical · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2021, registered Nov 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Psoriasis
  • Psoriatic Arthritis
  • Psoriatic Nail

Keywords

  • Psoriasis Nails
  • Psoriatic Arthritis
  • Enbrel
  • Biologic
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 10 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

OptiSkin Medical is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Moderate to severe psoriasis
  • Psoriasis affecting the fingernails

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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 · Device: OCT

Interventions

  • DrugEtanercept

    TNF-alpha inhibitors improve nail psoriasis.

    Also known as: Enbrel

  • DeviceOCT

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

    Also known as: Optical Coherence Tomography

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 24 weeks

  2. OCT (clinical)

    Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.

    Time frame: Baseline to 24 weeks

Secondary outcomes

  1. OCT (sub-clinical)

    Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails.

    Time frame: Baseline to 24 weeks

  2. Dermoscopy

    Dermoscopy allows for the examination of the skin using skin surface microscopy.

    Time frame: Baseline to 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05135312
Lead sponsor
OptiSkin Medical
Collaborators
Amgen
Responsible party
Orit Markowitz MD (Chief Medical Ofiicer, OptiSkin Medical) — Principal investigator
First posted
Nov 26, 2021
Start date
Aug 9, 2021
Primary completion
Aug 8, 2022 (estimated)
Completion
Aug 8, 2022 (estimated)
Last update
Jan 6, 2022

Study contacts

Moshe Bressler, DO
Contact
moshe@optiskinmedical.com
2128283120
Halima Amro, BS
Contact
halima@optiskinmedical.com
2128283120
Orit Markowitz, MD
principal investigator · OptiSkin Medical

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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