Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

NCT05135312 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: OPTI-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Psoriasis; Psoriatic Arthritis; Psoriatic Nail

Keywords

Psoriasis Nails; Psoriatic Arthritis; Enbrel; Biologic

Outcome Measures

Primary Outcomes (2)

• 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

• OCT (clinical)

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

  Baseline to 24 weeks

Secondary Outcomes (2)

• OCT (sub-clinical)

  Baseline to 24 weeks

• Dermoscopy

  Baseline to 24 weeks

Study Arms (1)

Etanercept

OTHER

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

Etanercept DRUG

TNF-alpha inhibitors improve nail psoriasis.

Also known as: Enbrel

Etanercept

OCT DEVICE

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

Also known as: Optical Coherence Tomography

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe psoriasis
• Psoriasis affecting the fingernails

You may not qualify if:

• 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

Sponsors & Collaborators

• OptiSkin Medical: lead
• Amgen: collaborator

Study Sites (1)

OptiSkin Medical

New York, New York, 10128, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Etanercept; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Orit Markowitz, MD

  OptiSkin Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Bressler, DO

CONTACT

2128283120; moshe@optiskinmedical.com

Halima Amro, BS

CONTACT

2128283120; halima@optiskinmedical.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Ofiicer

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 26, 2021
• Study Start: August 9, 2021
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)