Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT00176969
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Response of Topical Capsaicin in Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2000-06'}, 'lastUpdateSubmitDate': '2014-05-30', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.'}], 'secondaryOutcomes': [{'measure': 'The scalps of AA patients may be less sensitive to stimuli.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically mediated disease. Research supporting this theory includes the finding that nerves surrounding the hair follicles are collapsed. We want to take this research a step further and show that not only are these perifollicular nerves collapsed, but that their function is also impaired.', 'detailedDescription': 'To assess the function of perifollicular scalp nerves in AA we will look at the response of these nerves to the topical medication capsaicin. Under normal circumstances topical capsaicin is known to target nerves in the peripheral nervous system causing short-term release of the neuropeptide Substance P (SP) as well as long-term transient depletion of SP. We expect the AA patients will respond abnormally to topical capsaicin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have alopecia totalis or universalis.\n* Be in good health.\n* Not be taking any medications including topical medications\n* Be 18 years or older.\n* Be willing to apply study medication or vehicle as directed, comply with instructions and commit to follow-up visits.\n* Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study.\n\nExclusion Criteria:\n\n* Absence of extensive alopecia areata.\n* People not in good health.\n* People taking medications.\n* Allergies to capsaicin.\n* Presence of irritated or visibly inflamed scalp.\n* Having had hair chemically treated (including colored hair, permed hair, etc.) within the month prior to study.'}, 'identificationModule': {'nctId': 'NCT00176969', 'briefTitle': 'Response of Topical Capsaicin in Alopecia Areata', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin', 'orgStudyIdInfo': {'id': '9707M00122'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Capsaicin', 'type': 'DRUG'}]}, '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 Hordinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Marna Ericson, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}