Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05135312
Status:
UNKNOWN
Last Update Posted:
2022-01-06
First Post:
2021-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-08-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NAPSI', 'timeFrame': 'Baseline to 24 weeks', 'description': '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.'}, {'measure': 'OCT (clinical)', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.'}], 'secondaryOutcomes': [{'measure': 'OCT (sub-clinical)', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails.'}, {'measure': 'Dermoscopy', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Dermoscopy allows for the examination of the skin using skin surface microscopy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Psoriasis Nails', 'Psoriatic Arthritis', 'Enbrel', 'Biologic'], 'conditions': ['Psoriasis', 'Psoriatic Arthritis', 'Psoriatic Nail']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).\n\nOCT 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.\n\nStudy-related care and medication are provided at no cost, and reimbursement for reasonable local transportation may be available to qualified individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe psoriasis\n* Psoriasis affecting the fingernails\n\nExclusion Criteria:\n\n* Previous treatment with Enbrel® (etanercept)\n* Active infection\n* Rheumatoid arthritis\n* Any personal or family history of any neurologic demyelinating disease\n* Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit'}, 'identificationModule': {'nctId': 'NCT05135312', 'briefTitle': 'Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging', 'organization': {'class': 'OTHER', 'fullName': 'OptiSkin Medical'}, 'officialTitle': 'Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'OPTI-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Etanercept', 'description': '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.', 'interventionNames': ['Drug: Etanercept', 'Device: OCT']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': 'TNF-alpha inhibitors improve nail psoriasis.', 'armGroupLabels': ['Etanercept']}, {'name': 'OCT', 'type': 'DEVICE', 'otherNames': ['Optical Coherence Tomography'], 'description': 'Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.', 'armGroupLabels': ['Etanercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10128', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Moshe Bressler, DO', 'role': 'CONTACT', 'email': 'moshe@optiskinmedical.com', 'phone': '212-828-3120'}, {'name': 'Halima Amro, BS', 'role': 'CONTACT', 'email': 'halima@optiskinmedical.com', 'phone': '2128283120'}], 'facility': 'OptiSkin Medical', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Moshe Bressler, DO', 'role': 'CONTACT', 'email': 'moshe@optiskinmedical.com', 'phone': '2128283120'}, {'name': 'Halima Amro, BS', 'role': 'CONTACT', 'email': 'halima@optiskinmedical.com', 'phone': '2128283120'}], 'overallOfficials': [{'name': 'Orit Markowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OptiSkin Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OptiSkin Medical', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Ofiicer', 'investigatorFullName': 'Orit Markowitz MD', 'investigatorAffiliation': 'OptiSkin Medical'}}}}