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Biological Response Modifier

Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

Phase 4
Waitlist Available
Led By Orit Markowitz, MD
Research Sponsored by OptiSkin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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).

Eligible Conditions
  • Psoriasis
  • Psoriatic Arthritis
  • Psoriatic Nails

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NAPSI
OCT (clinical)
Secondary study objectives
Dermoscopy
OCT (sub-clinical)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EtanerceptExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
2005
Completed Phase 4
~4720
OCT
2016
N/A
~1270

Find a Location

Who is running the clinical trial?

OptiSkin MedicalLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
AmgenIndustry Sponsor
1,447 Previous Clinical Trials
1,398,202 Total Patients Enrolled
76 Trials studying Psoriasis
116,503 Patients Enrolled for Psoriasis
Orit Markowitz, MDPrincipal InvestigatorOptiSkin Medical
2 Previous Clinical Trials
36 Total Patients Enrolled
~2 spots leftby Dec 2025
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