Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT03155958
Status:
UNKNOWN
Last Update Posted:
2017-05-16
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Finding in Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patient with occular affection in alopecia areata', 'timeFrame': '2 years', 'description': 'percentage'}], 'secondaryOutcomes': [{'measure': 'correlate dermoscopic finding with disease severity and ocular finding', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hair Loss']}, 'referencesModule': {'references': [{'pmid': '10727299', 'type': 'BACKGROUND', 'citation': 'Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.'}, {'pmid': '27061214', 'type': 'BACKGROUND', 'citation': 'Esmer O, Karadag R, Cakici O, Bilgili SG, Demircan YT, Bayramlar H, Karadag AS. Ocular findings in patients with alopecia areata. Int J Dermatol. 2016 Jul;55(7):814-8. doi: 10.1111/ijd.13114. Epub 2016 Apr 7.'}, {'pmid': '26147700', 'type': 'BACKGROUND', 'citation': 'Ergin C, Acar M, Kaya Akis H, Gonul M, Gurdal C. Ocular findings in alopecia areata. Int J Dermatol. 2015 Nov;54(11):1315-8. doi: 10.1111/ijd.12897. Epub 2015 Jul 3.'}, {'pmid': '3549809', 'type': 'BACKGROUND', 'citation': 'Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.'}, {'pmid': '19382996', 'type': 'BACKGROUND', 'citation': 'Pandhi D, Singal A, Gupta R, Das G. Ocular alterations in patients of alopecia areata. J Dermatol. 2009 May;36(5):262-8. doi: 10.1111/j.1346-8138.2009.00636.x.'}, {'pmid': '10696317', 'type': 'BACKGROUND', 'citation': 'Recupero SM, Abdolrahimzadeh S, De Dominicis M, Mollo R, Carboni I, Rota L, Calvieri S. Ocular alterations in alopecia areata. Eye (Lond). 1999 Oct;13 ( Pt 5):643-6. doi: 10.1038/eye.1999.174.'}, {'pmid': '16394450', 'type': 'BACKGROUND', 'citation': 'Nischal KC, Khopkar U. Dermoscope. Indian J Dermatol Venereol Leprol. 2005 Jul-Aug;71(4):300-3. doi: 10.4103/0378-6323.16633. No abstract available.'}, {'pmid': '18613874', 'type': 'BACKGROUND', 'citation': 'Inui S, Nakajima T, Nakagawa K, Itami S. Clinical significance of dermoscopy in alopecia areata: analysis of 300 cases. Int J Dermatol. 2008 Jul;47(7):688-93. doi: 10.1111/j.1365-4632.2008.03692.x.'}]}, 'descriptionModule': {'briefSummary': 'Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of hair loss.\n\nSeveral etiological factors, including psychological, trauma-related, genetic and autoimmune factors have been considered as possible etiological factors . A T cell-mediated autoimmune mechanism in genetically vulnerable individuals is the most acceptable etiology.\n\nAlopecia areata presents clinically with well demarcated patches of non cicatricial hair loss in any hair bearing area with no remarkable gender preference.\n\nAlthough AA may occur at any age, incidence is high among younger age groups. In fact, it is the most common form of alopecia seen in children. Various clinical patterns of alopecia have been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis (complete loss of scalp hair), and alopecia universalis (complete loss of body hair).\n\nNational Alopecia Areata Foundation has devised "Severity of Alopecia Tool Score" (SALT score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT score is the sum of percentage of hair loss in the above mentioned areas.', 'detailedDescription': 'Alopecia areata is now considered a systemic autoimmune disease that may have other serious comorbidities, such as cardiovascular and ocular. However, the results of studies of ocular findings in AA are controversial.\n\nSeveral ocular alterations have been previously reported in patients with AA ranging from minor punctate opacities to cataract. However, there are contrasting opinions on the significance of these lenticular changes. In addition, Horner syndrome, pupil ectopia, iris atrophy, fundus changes , bilateral keratoconus, iris changes and retinal changes have been reported in AA.\n\nDermoscopy is a noninvasive, diagnostic tool which visualizes subtle patterns of skin lesions not normally visible to the unaided eye. Characteristic dermoscopic finding of AA included black dots , tapering hair corresponding to " exclamation mark hairs " , broken hairs , yellow dots , and clustered short vellus hairs ( shorter than 10 mm).\n\nSince ocular affection can be a profound morbidity factor in patients with AA, we will search deeply in this study about this correlation in order to conclude the value of ocular screening in each and every patient with AA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients of alopecia areata will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.\n\nExclusion Criteria:\n\n1. Patients with documented eye disease.\n2. Patients with any systemic illness.\n3. Patients who received any systemic treatment with possible ocular implications in the last three months."}, 'identificationModule': {'nctId': 'NCT03155958', 'briefTitle': 'Ocular Finding in Alopecia Areata', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ocular Comorbidities of Alopecia Areata', 'orgStudyIdInfo': {'id': 'OCCAA'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eman Riad, MD', 'role': 'CONTACT', 'email': 'E_raid@aun.edu.eg', 'phone': '00201005298992'}, {'name': 'Ayman Mohamed, MD', 'role': 'CONTACT', 'email': 'aymanderma@yahoo.com', 'phone': '00201009948311'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Walaa Mahmoud', 'investigatorAffiliation': 'Assiut University'}}}}