[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402434":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":29,"interventions":37,"overallOfficials":45,"centralContacts":49,"locations":57,"responsibleParty":72,"collaborators":22,"id":74,"slug":22,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":22,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":22,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":22,"overallStatus":60,"whyStopped":22,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Wright State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":22},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Change in microvesicle particle levels from baseline in clinically photosensitive subjects","This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J\u002Fm2.","4 Hours",{"measure":14,"description":15,"timeFrame":12},"Change in microvesicle particle levels from baseline post topical imipramine application","This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J\u002Fm2.",{"measure":17,"description":18,"timeFrame":12},"Change in skin erythema from baseline on topical imipramine treated skin","This will be measured with a mexameter at 4 hours.",{"measure":17,"description":20,"timeFrame":21},"This will be measured with a mexameter at 24 hours.","24 Hours",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SINGLE_GROUP","PREVENTION",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE",[30],{"label":31,"type":32,"description":33,"interventionNames":34},"4% Imipramine Cream on UVB-Treated Areas","EXPERIMENTAL","* 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back.\n* 2g of base cream will be applied to the UVB-treated areas on volar forearm and back.\n* No cream will be applied to a UVB-treated area on the back",[35,36],"Drug: 4% Imipramine Cream","Drug: Base Cream",[38,42],{"type":39,"name":40,"description":40,"armGroupLabels":41,"otherNames":22},"DRUG","4% Imipramine Cream",[31],{"type":39,"name":43,"description":43,"armGroupLabels":44,"otherNames":22},"Base Cream",[31],[46],{"name":47,"affiliation":5,"role":48},"Jeffrey B Travers, MD, PhD","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":22,"email":54},"Manager Clinical Research Operations","CONTACT","937-245-7500","pturesearch@wrightstatephysicians.org",{"name":56,"role":52,"phone":53,"phoneExt":22,"email":54},"Regulatory Specialist",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":22},"Wright State Physicians","RECRUITING","Fairborn","Ohio","45324","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-84.01938,39.82089,{"lat":70,"lon":69},{"type":73,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100402434",false,"NCT04520217","Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects","Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects","Inclusion Criteria:\n\n* Female and Male adult subjects age 18 to 50\n* Must be able to give informed consent\n* Have access to stable transportation\n* All skin types on Fitzpatrick Scale (Type I-VI)\n* Self-Identified photosensitivity\n* Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer.\n\nExclusion Criteria:\n\n* Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)\n* Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS \\[except for low-dose aspirin\\] or steroids)\n* Utilizing imipramine or any other tricyclic antidepressant (oral or cream)\n* Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)\n* Large tattoos in the designated testing areas\n* Tanning bed use within last 3 months\n* Photodynamic Therapy or UVB treatments in past 3 months\n* Female Subjects: pregnant or nursing\n* History of abnormal scarring (i.e., keloids)",true,"ALL","18 Years","50 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).",[92,93],"Photosensitivity","Microvesicle Particle","2025-01-24",{"date":96,"type":97},"2025-01-27","ACTUAL",{"date":99,"type":97},"2022-06-06",{"date":101,"type":86},"2026-12-01",{"name":5,"class":6},1]