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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05135312
Other study ID # OPTI-004
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 9, 2021
Est. completion date August 8, 2022

Study information

Verified date December 2021
Source OptiSkin Medical
Contact Moshe Bressler, DO
Phone 2128283120
Email moshe@optiskinmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 EnbrelĀ® (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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 8, 2022
Est. primary completion date August 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Moderate to severe psoriasis - Psoriasis affecting the fingernails Exclusion Criteria: - Previous treatment with EnbrelĀ® (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


Intervention

Drug:
Etanercept
TNF-alpha inhibitors improve nail psoriasis.
Device:
OCT
Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.

Locations

Country Name City State
United States OptiSkin Medical New York New York

Sponsors (2)

Lead Sponsor Collaborator
OptiSkin Medical Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary OCT (clinical) Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity. Baseline to 24 weeks
Secondary OCT (sub-clinical) Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails. Baseline to 24 weeks
Secondary Dermoscopy Dermoscopy allows for the examination of the skin using skin surface microscopy. Baseline to 24 weeks
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