Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT04588532
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571042', 'term': 'bovine adrenal medulla 8-22'}, {'id': 'D006632', 'term': 'Histamine'}, {'id': 'D004316', 'term': 'Doxepin'}], 'ancestors': [{'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D010082', 'term': 'Oxepins'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D003990', 'term': 'Dibenzoxepins'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'superficial blood perfusion', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'is measured by a speckle contrast imager (FLPI, Moor Instruments, England)'}, {'measure': 'Warm Detection Threshold, and Heat Pain threshold', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device'}, {'measure': 'Cold Detection Threshold and Cold Pain threshold', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device'}, {'measure': 'Pain supra-threshold heat Stimuli', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device'}, {'measure': 'hyperknesis (abnormal pruriceptive state)', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'is measured by using a mildly pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)'}, {'measure': 'mechanical pain threshold and sensitivity', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications'}, {'measure': 'itch rating', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"'}], 'secondaryOutcomes': [{'measure': 'pain rating', 'timeFrame': 'change from baseline, up to 10 minutes after the first session', 'description': 'the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no pain" and 100 indicates "worst imaginable pain"'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Itch']}, 'descriptionModule': {'briefSummary': 'With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.', 'detailedDescription': 'With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.\n\nThe experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* 18-60 years\n* Speak and understand English\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Drug addiction defined as any use of cannabis, opioids or other drugs\n* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)\n* Moles, wounds, scars or tattoos in the area to be treated or tested\n* Lack of ability to cooperate •\n* Current use of medications that may affect the trial such as antihistamines and pain killers.\n* Skin diseases\n* Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •\n* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)'}, 'identificationModule': {'nctId': 'NCT04588532', 'briefTitle': 'Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch', 'orgStudyIdInfo': {'id': 'N-20190062 2nd project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'doxepin', 'description': 'Drug: Doxepin + BAM8-22 Doxepin will be applied for 1.5 hrs followed by the application of BAM8-22. 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop\n\nDrug: Doxepin + Histamine Doxepin will be applied for 1.5 hrs followed by the application of Histamine. 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop\n\nDrug: Doxepin + Cowhage Doxepin will be applied for 1.5 hrs followed by the application of cowhage. 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop\n\nDrug: Doxepin + Placebo Doxepin will be applied for 1.5 hrs followed by the application of placebo. 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop', 'interventionNames': ['Drug: BAM8-22', 'Drug: Histamine', 'Drug: Cowhage (Mucuna Pruriens)', 'Drug: Doxepin']}, {'type': 'EXPERIMENTAL', 'label': 'itch', 'description': 'Drug: BAM8-22 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop\n\nDrug: Histamine 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop\n\nDrug: Cowhage 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop\n\nDrug: Placebo 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop', 'interventionNames': ['Drug: BAM8-22', 'Drug: Histamine', 'Drug: Cowhage (Mucuna Pruriens)']}], 'interventions': [{'name': 'BAM8-22', 'type': 'DRUG', 'description': 'Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)', 'armGroupLabels': ['doxepin', 'itch']}, {'name': 'Histamine', 'type': 'DRUG', 'description': 'histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)', 'armGroupLabels': ['doxepin', 'itch']}, {'name': 'Cowhage (Mucuna Pruriens)', 'type': 'DRUG', 'description': 'cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)', 'armGroupLabels': ['doxepin', 'itch']}, {'name': 'Doxepin', 'type': 'DRUG', 'description': 'Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm', 'armGroupLabels': ['doxepin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, PhD fellow', 'investigatorFullName': 'Giulia Erica Aliotta', 'investigatorAffiliation': 'Aalborg University'}}}}