PsoriasisPhase 4NCT05135312
Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging
A Phase 4 study testing Etanercept and OCT in people with Psoriasis and Psoriatic Arthritis, run by OptiSkin Medical at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis, Psoriatic Nail
- What is being tested?
- Etanercept and OCT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 8 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe psoriasis
- Psoriasis affecting the fingernails
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OptiSkin Medical
New York, New York, 10128
Moshe Bressler, DO, 212-828-3120, moshe@optiskinmedical.com
Halima Amro, BS, 2128283120, halima@optiskinmedical.com
About this study
Official title: Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography
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.
- Conditions
- Psoriasis, Psoriatic Arthritis, Psoriatic Nail
- Being tested
- Etanercept, OCT
- Keywords
- Psoriasis Nails, Psoriatic Arthritis, Enbrel, Biologic
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
TNF-alpha inhibitors improve nail psoriasis.
OCTDevice
Also called Optical Coherence Tomography
Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Etanercept; Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 weeks
OCT (clinical)
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
Measured: Baseline to 24 weeks
Secondary outcomes (2)
OCT (sub-clinical)
Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails.
Measured: Baseline to 24 weeks
Dermoscopy
Dermoscopy allows for the examination of the skin using skin surface microscopy.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start9 Aug 2021
- Primary completion8 Aug 2022 (estimated)
- Study completion8 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OptiSkin Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Orit Markowitz MD, OptiSkin Medical
- Investigators
- Orit Markowitz, MD, Principal investigator, OptiSkin Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135312
- Sponsor's protocol ID
- OPTI-004
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05135312
- Acronym / sponsor ID
- OPTI-004
- Conditions
- Psoriasis, Psoriatic Arthritis, Psoriatic Nail
- Keywords
- Psoriasis Nails, Psoriatic Arthritis, Enbrel, Biologic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- OptiSkin MedicalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 8 Aug 2022 (estimated)
- Study completion
- 8 Aug 2022 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Other | Drug: Etanercept, Device: OCT50mg 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe psoriasis
- Psoriasis affecting the fingernails
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelTNF-alpha inhibitors improve nail psoriasis. | Drug | Etanercept |
| OCTAlso: Optical Coherence TomographyOptical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity. | Device | Etanercept |
Primary outcome
NAPSI
Time frame: Baseline to 24 weeks
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.
OCT (clinical)
Time frame: Baseline to 24 weeks
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
2 secondary outcomes
OCT (sub-clinical)
Time frame: Baseline to 24 weeks
Dermoscopy
Time frame: Baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orit Markowitz, MD principal investigator
OptiSkin Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept and OCT in people with Psoriasis and Psoriatic Arthritis, run by OptiSkin Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Bressler, DO (2128283120, moshe@optiskinmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAPSI (time frame: Baseline to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.