Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 8:01 PM
Study NCT ID:
NCT06444594
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transient Receptor Potential Channels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008610', 'term': 'Menthol'}, {'id': 'D002164', 'term': 'Camphor'}, {'id': 'D002211', 'term': 'Capsaicin'}, {'id': 'C416986', 'term': 'TRPV4 protein, human'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001892', 'term': 'Camphanes'}, {'id': 'D000081008', 'term': 'Bicyclic Monoterpenes'}, {'id': 'D001643', 'term': 'Bridged Bicyclo Compounds'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D009636', 'term': 'Norbornanes'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin blood flow during slow local heating', 'timeFrame': '75 minutes', 'description': 'Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin'}, {'measure': 'Somatosensory perception', 'timeFrame': 'every 5 minutes for 120 minues', 'description': 'heat and cold perception using a visual analog scale'}, {'measure': 'algometer measurement', 'timeFrame': 'every 30 minutes for 120 minutes', 'description': 'pain pressure thresholds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'Neurovascular signaling in the skin associated with stimulation of the transient receptor potential (TRP) channels. These channels are stimulated by both temperature and naturally occurring bioactive agents found in mint, chili peppers, garlic, etc. The aim of the study is to examine how topically applied TRP channel agonists including menthol, capsaicin and camphor impact neurovascular responses in the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-85 years old.\n* Women will not be pregnant and/or breastfeeding.\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding\n* Nicotine use (e.g., smoking, chewing tobacco etc.), quantified as more than 100 cigarettes or cigars in a lifetime)\n* Known skin allergies or current rash, skin disease, disorders of pigmentation\n* Diabetes\n* Body mass index \\>35kg\\*m-2\n* Using calcium channel blockers\n* Raynaud's syndrome\n* Allergy or hypersensitivity to menthol, camphor, capsaicin or adhesive\n* Regular use (defined as greater than once a week) of topical analgesics that contain menthol, camphor or capsaicin"}, 'identificationModule': {'nctId': 'NCT06444594', 'acronym': 'TRP', 'briefTitle': 'Transient Receptor Potential Channels', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Transient Receptor Potential Channels in Human Skin', 'orgStudyIdInfo': {'id': '24921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Gel', 'description': 'Non-active topical gel', 'interventionNames': ['Other: Vehicle gel']}, {'type': 'EXPERIMENTAL', 'label': 'Transient Receptor Potential (M8) Agonist', 'description': 'Topical menthol gel applied once at 10%', 'interventionNames': ['Drug: TRPM8 Agonist']}, {'type': 'EXPERIMENTAL', 'label': 'Transient Receptor Potential (V4) Agonist', 'description': 'Topical capsaicin gel applied once at 0.05%', 'interventionNames': ['Drug: TRPV4 Agonist']}, {'type': 'EXPERIMENTAL', 'label': 'Transient Receptor Potential (V1) Agonist', 'description': 'Topical camphor gel applied once at 0.6%', 'interventionNames': ['Drug: TRPV1 Agonist']}, {'type': 'EXPERIMENTAL', 'label': 'Transient Receptor Potential M8 V4 V1 Agonist', 'description': 'Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once', 'interventionNames': ['Drug: TRPM8, TRPV4, TRPV1 Agonists']}, {'type': 'NO_INTERVENTION', 'label': 'no gel', 'description': 'no gel comparison'}], 'interventions': [{'name': 'TRPM8 Agonist', 'type': 'DRUG', 'otherNames': ['menthol'], 'description': 'menthol gel 4-10%', 'armGroupLabels': ['Transient Receptor Potential (M8) Agonist']}, {'name': 'TRPV1 Agonist', 'type': 'DRUG', 'otherNames': ['camphor'], 'description': 'camphor gel 5-20%', 'armGroupLabels': ['Transient Receptor Potential (V1) Agonist']}, {'name': 'TRPV4 Agonist', 'type': 'DRUG', 'otherNames': ['capsaicin'], 'description': 'capsaicin gel 0.05-1%%', 'armGroupLabels': ['Transient Receptor Potential (V4) Agonist']}, {'name': 'TRPM8, TRPV4, TRPV1 Agonists', 'type': 'DRUG', 'otherNames': ['menthol, capsaicin, camphor'], 'description': 'menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)', 'armGroupLabels': ['Transient Receptor Potential M8 V4 V1 Agonist']}, {'name': 'Vehicle gel', 'type': 'OTHER', 'otherNames': ['Inactive vehicle gel'], 'description': 'Inactive vehicle gel', 'armGroupLabels': ['Vehicle Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lacy Alexander, Ph.D.', 'role': 'CONTACT', 'email': 'lma191@psu.edu', 'phone': '814-867-1781'}, {'name': 'Sue Slimak, R.N.', 'role': 'CONTACT', 'email': 'sks31@psu.edu'}], 'facility': 'Noll Laboratory', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'centralContacts': [{'name': 'Lacy Alexander, Ph.D.', 'role': 'CONTACT', 'email': 'lma191@psu.edu', 'phone': '8148671781'}, {'name': 'Sue K Slimak, R.N.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Lacy Alexander, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Kinesiology', 'investigatorFullName': 'Lacy Alexander', 'investigatorAffiliation': 'Penn State University'}}}}