Recruiting

Etanercept

Sponsor:

OptiSkin Medical

Code:

NCT05135312

Conditions

Psoriasis

Psoriatic Arthritis

Psoriatic Nail

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etanercept

OCT

Study Details

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

Study ID

NCT05135312

Start date

Aug 9, 2021

Status verified date

Dec, 2021

Completion date

Aug 8, 2022

Anticipated

Primary completion date

Aug 8, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Etanercept

TNF-alpha inhibitors improve nail psoriasis.

OCT

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

Primary outcome measure

  • NAPSI [ Time Frame: Baseline to 24 weeks ]
  • OCT (clinical) [ Time Frame: Baseline to 24 weeks ]

Central Contacts and Locations

Central contacts

Moshe Bressler, DO

2128283120moshe@optiskinmedical.com

Halima Amro, BS

2128283120halima@optiskinmedical.com

Locations

OptiSkin Medical

Recruiting

New York, New York, United States, 10128

Contacts

Moshe Bressler, DO

212-828-3120moshe@optiskinmedical.com

Halima Amro, BS

2128283120halima@optiskinmedical.com

More Information

Sponsor

OptiSkin Medical

Last update posted

Jan 6, 2022

Last verified

Dec, 2021

Keywords

  • Psoriasis Nails
  • Psoriatic Arthritis
  • Enbrel
  • Biologic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OptiSkin Medical on 2022-01-06.