Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 5:04 AM
Study NCT ID:
NCT06696612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermoscopy in Nails
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046169', 'term': 'Dermoscopy'}], 'ancestors': [{'id': 'D000069416', 'term': 'Intravital Microscopy'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nail changes in Vitiligo', 'timeFrame': 'At enrollment', 'description': 'Dermoscopic pictures of the nails'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Vitiligo', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Study types and frequency of nail changes in patients with vitiligocompared to healthy subjects', 'detailedDescription': 'Dermoscopy is a noninvasive diagnostic tool that is currently being used for different skin lesions, several inflammatory \\& infectious diseases, and skin appendages disorders. ") In daily practice, dermoscopy may confirm clinical diagnosis and guides in the management of nail diseases, permitting a better visualization of symptoms. (2) Nail dermoscopy (Onychoscopy) was initially used only in the assessment of nail pigmentation, but now it is widely utilized for the evaluation of many nail disorders. (3) It enhances visible nail features; however, it can also help identify additional unique and fascinating features not visible to the naked eye. 2) Vitiligo is an acquired dyschromia of the skin in which there is loss of epidermal melanocytes The prevalence of vitiligo is approximately 0.1 - 2% worldwide. (5) Vitiligo is classified as segmental, acrofacial, generalized, and universal and less commonly mucosal and trichome.\n\nVitiligo has been described as a systemic disease. It has been associated with other autoimmune disorders as Diabetes (DM), Lupus, Psoriasis, Alopecia areata (AA), Hashimoto thyroiditis, and Gravesdisease.\n\nNails can show changes in association with many disorders such as renal, hepatic, pulmonary, autoimmune and collagen diseases. (67) Dermoscopic nail changes has been reported in several autoimmune disorders such as, in DM; longitudinal striations, pitting, onycholysis, \\& splinter hemorrhage, (® in AA; scaly cuticle, punctate leukonychia, oncholysis, \\&oncychoschizia®and in Collagen Vascular disorders; dilated capillaries, capillary dropout, and avascular areas. (10) To the best of our knowledge, dermoscopic nail changes in vitiligo haven\'t been reported yet. However, few studies had discussed clinical nail changes in vitiligo such as: (11) longitudinal ridging, absent lunula, leukonychia, pitting, in addition to less common nail changes such as flag sign and Terry\'s nails'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Vitiligo patients attending dermatology outpatient clinic of Assiut University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age Adults patients 12-50 years old All types of vitiligo: Focal, generalized, acrofacial, segmental\n\nExclusion Criteria:\n\n* patients older than 50 (because of aging's nail changes Patients with autoimmune disorders Patients using systemic medication for any reason including oral contraceptive pill"}, 'identificationModule': {'nctId': 'NCT06696612', 'briefTitle': 'Dermoscopy in Nails', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Dermoscopic Nail Changes in Vitiligo', 'orgStudyIdInfo': {'id': 'Nail Dermoscopy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dermoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Dermoscopic examination of the nails'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rehab S.A. Sotohy', 'role': 'CONTACT', 'email': 'rehabsotohy@yahoo.com', 'phone': '+201000781890'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate student', 'investigatorFullName': 'Rehab Sotohy Ahmad Sotohy', 'investigatorAffiliation': 'Assiut University'}}}}