[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100264949":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":57,"collaborators":30,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":30,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PDT Treatment","EXPERIMENTAL","Each subject will have either placebo or Levulan Kerastick topical application applied to matched sets of neurofibromas. Each subject will have both sets, in order to serve as his\u002Fher own control subject.\n\n16 to 24 hours post study drug treatment, both sets of neurofibromas, Levulan and placebo treated, will be irradiated with red light (630 nm) from an Omnilux Revive light device at 100 mW\u002Fcm2 for 1000 seconds (16.7 minutes).",[13],"Drug: aminolevulinic acid",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","aminolevulinic acid","Drug: Levulan Kerastick\n\nDrug: Topical placebo\n\nDevice: Omnilux Revive\n\nProcedure: Photodynamic therapy\n\nOther: Tumor growth rate measurements",[9],[21],"Photodynamic therapy",[23],{"name":24,"affiliation":5,"role":25},"Donald G Basel, MD","STUDY_DIRECTOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","414-266-4921",null,"dbasel@mcw.edu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Paula Engelking, BS, CRC","414-266-3289","pengelki@mcw.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Donald G Basel","RECRUITING","Milwaukee","Wisconsin","53226","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-87.90647,43.0389,{"lat":49,"lon":48},[52,54],{"name":24,"role":28,"phone":53,"phoneExt":30,"email":31},"4142664921",{"name":55,"role":28,"phone":56,"phoneExt":30,"email":35},"Paula Engelking","4142663289",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Donald Basel","Professor","100264949","phase-2-photodynamic-therapy-for-benign-dermal-neurofibromas--phase-ii-100264949",false,"NCT02728388","Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II","Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II","Inclusion Criteria:\n\n1. Patient is 14 years or older.\n2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section).\n3. Tumor Location: cutaneous, trunk, or limbs only.\n4. Tumor Type: superficial dermal neurofibromas ≤4mm deep.\n5. Patient has provided written informed consent.\n6. Patient is willing to and can comply with study follow-up requirements.\n7. Absence of any other malignancy.\n\nExclusion Criteria:\n\n1. Life expectancy less than 3 years.\n2. Pregnancy.\n3. Cutaneous photosensitivity to the wavelengths used to active PDT.\n4. A diagnosis of porphyria.\n5. Allergy to aminolevulinic acid or any of the topical solution vehicle components.\n6. Previous chemotherapy within 6 weeks of proposed PDT.\n7. Other concurrent tumor therapy.","ALL","14 Years","30 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1).\n\nThe investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.",[79],"NEUROFIBROMATOSIS 1",[81,82,83],"NF1","Neurofibroma","Neurofibromatosis Type 1","2025-05-05",{"date":86,"type":87},"2025-05-08","ACTUAL",{"date":89,"type":87},"2016-08",{"date":91,"type":73},"2025-12",{"name":59,"class":6},1]