Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-02-01 @ 9:41 PM
Study NCT ID:
NCT03346668
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D008010', 'term': 'Lichen Planus'}], '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'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-28', 'size': 532102, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-09-07T12:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2017-09-08', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurogenic inflammation-QOL', 'timeFrame': 'Change from Baseline to 14 weeks', 'description': 'Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)'}, {'measure': 'Neurogenic inflammation-Short Form (36) Health Survey', 'timeFrame': 'Change from Baseline to 14 weeks', 'description': 'Complete Short Form (36) Health Survey Scale Scale=1-5 1 being the best and 5 being the worse'}, {'measure': 'Neurogenic inflammation- Visual Analog pain Scale', 'timeFrame': 'Change from Baseline to 14 weeks', 'description': 'Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain'}], 'secondaryOutcomes': [{'measure': 'Safety and efficacy of topical 6% gabapentin -Medication side Effects', 'timeFrame': 'Change from Baseline to 12 weeks', 'description': 'Subjects will have Medication side effects collected at day 0 and ending week 12'}, {'measure': 'Safety and efficacy of topical 6% gabapentin -Blood levels', 'timeFrame': 'Change from Baseline to 12 weeks', 'description': 'Subjects will have blood levels measured at Day 0 and 12 weeks'}, {'measure': 'Safety and efficacy of topical 6% gabapentin -Adverse Events', 'timeFrame': 'Change from Baseline to 12 weeks', 'description': 'Subjects will have adverse events collected on day 0 and 12 weeks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scarring Alopecia', 'Frontal Fibrosing Alopecia', 'Lichen Planopilaris', 'Central Centrifugal Cicatricial Alopecia', 'Central Centrifugal Scarring Alopecia']}, 'descriptionModule': {'briefSummary': 'This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia.', 'detailedDescription': 'Primary scarring alopecias (PSAs) are poorly understood dermatologic disorders that result in permanent hair loss. Most of the scarring alopecias involve a painful course, with individuals reporting scalp pain, burning, itching, or tingling/crawling sensations that can ultimately impact physical and psychological health. There has been no study of topical neurogenic agents, such as gabapentin, to treat scarring alopecia. However topical gabapentin has been safely used in other conditions associated with chronic pain, burning, irritation, itch, or tingling, such as vulvodynia. This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia. In this study, 10 subjects with symptomatic lymphocytic-type scarring alopecia will be recruited and treated with topical gabapentin. Disease burden will be evaluated before and after 12 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, clinical assessment, and biopsies measuring levels of CGRP before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female adults, greater than 18 years of age\n2. Biopsy-proven diagnosis of primary scarring alopecia of lymphocytic inflammatory infiltrate type, indicated as one of the following conditions: lichen planopilaris, frontal fibrosing alopecia, or central centrifugal cicatricial alopecia\n3. At least one persistent scalp symptom associated with inflammation: pain, burning, itch, tingling/crawling, stinging, or tenderness\n4. Able to complete survey and questionnaire subjectively\n5. Consents to participate in neurometer study and scalp biopsy acquisition\n6. Willingness to adhere to study protocol\n7. If subject is taking a neuromodulatory medication (including capsaicin cream, tricyclic antidepressants, carbamazepine, phenytoin, topiramate, oxcarbazepine, lamotrigine, morphine, Botox, etc), he or she must be a stable dose for at least 6 months prior to study enrollment\n\nExclusion Criteria:\n\n1. Allergy or intolerance to gabapentin or the substances used in its compounding\n2. Underlying disease that might be adversely affected by topical gabapentin\n3. Application of topical immunomodulatory or immunosuppressive agent to the scalp in the preceding 2 weeks\n4. Systemic administration of corticosteroid or other systemic treatment (i.e., methotrexate, phototherapy) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks\n5. Clinical evidence of secondary skin infection\n6. Individuals who have undergone scalp reduction surgery or hair transplantation\n7. Asymptomatic disease\n8. Immunosuppression due to disease state or use of systemic/topical biological agents (HIV, chemotherapy, immunomodulators, history of transplantation)\n9. Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents)\n10. Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months\n11. Use of illicit drugs or opioid medications\n12. Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study\n13. Implantable Cardioverter Defibrillator (ICD) or pacemaker\n14. Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications"}, 'identificationModule': {'nctId': 'NCT03346668', 'briefTitle': 'Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia', 'orgStudyIdInfo': {'id': '110336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical gabapentin', 'description': 'gabapentin 6% solution, 1mL applied twice daily for 12 weeks', 'interventionNames': ['Drug: Topical gabapentin']}], 'interventions': [{'name': 'Topical gabapentin', 'type': 'DRUG', 'otherNames': ['gabapentin 6% solution'], 'description': 'topical gabapentin 6% solution', 'armGroupLabels': ['Topical gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Maria K Hordinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}