Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT03082560
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2017-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design and Validation of a New Assessment Tool for Lichen Planopilaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008010', 'term': 'Lichen Planus'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-24', 'studyFirstSubmitDate': '2017-03-13', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)', 'timeFrame': '6 months', 'description': 'Design and validate a grading system for objective and accurate assessment of lichen planopilaris.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lichen Planopilaris of Scalp', 'Lichen Plano-Pilaris', 'Lichen Planopilaris', 'Frontal Fibrosing Alopecia']}, 'descriptionModule': {'briefSummary': "The study's Primary Objective is to design and validate a grading system for objective and accurate assessment of lichen planopilaris.\n\nSecondary Objectives:\n\n* To assess change in symptoms such as pain and itch using a Numeric Rating Scale(NRS) scores and quality of life using the Dermatology Life Quality Index (DLQI) scores\n* To correlate this grading system with patient skin biopsies evaluating disease activity on a microscopic level\n* To correlate this grading system with digital global photography and trichoscopy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult subjects with lichen planopilaris', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects in general good health between the ages of 18 and 80 years old\n2. Clinical and histologic diagnosis of lichen planopilaris\n3. Subject is able to understand and sign informed consent\n4. Subject is able to complete the study and comply with study procedures\n5. Subject has no known allergy to non-toxic ink\n6. Subjects should be managed by an Massachusetts General Hospital dermatologist for their lichen planopilaris for the duration of the study\n\nExclusion Criteria:\n\nEligible subjects will be excluded from participation if they meet any of the following criteria:\n\n1. Presence of dermatoses that might interfere with LPP diagnosis and/or evaluation such as seborrheic dermatitis or psoriasis\n2. Other selected concomitant causes of hair loss, including discoid lupus erythematosus, central centrifugal cicatricial alopecia (CCCA), telogen effluvium\n3. Abnormal TSH laboratory value \\>1 standard deviation above normal within last year\n4. Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment\n5. Any known allergy to non-toxic ink Related to Biopsy\n6. History of poor wound healing or blood-clotting abnormality\n7. History of keloid formation or hypertrophic scarring\n8. Regular intake of high doses of aspirin or anti-coagulant medications\n9. Hypersensitivity to local anesthetics\n10. History of poorly controlled diabetes mellitus\n11. Pregnant, nursing or planning a pregnancy"}, 'identificationModule': {'nctId': 'NCT03082560', 'briefTitle': 'Design and Validation of a New Assessment Tool for Lichen Planopilaris', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Design and Validation of a New Assessment Tool for Lichen Planopilaris, the Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)', 'orgStudyIdInfo': {'id': '2016P002620'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Healthy adult patients with lichen planopilaris', 'interventionNames': ['Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris']}], 'interventions': [{'name': 'Boston Grade of Activity in Lichen Planopilaris', 'type': 'DIAGNOSTIC_TEST', 'description': 'A clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Maryanne Senna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist', 'investigatorFullName': 'Maryanne Makredes Senna', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}