[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552235":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":40,"responsibleParty":297,"collaborators":32,"id":299,"slug":32,"hasResults":300,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":300,"sex":306,"minAge":307,"maxAge":32,"enrollmentInfo":308,"targetDuration":32,"studyType":311,"phases":312,"briefSummary":314,"conditions":315,"keywords":32,"overallStatus":56,"whyStopped":32,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},{"fullName":5,"class":6},"Soligenix","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HyBryte (0.25% Hypericin)","EXPERIMENTAL","HyBryte gel is applied twice weekly for 18 weeks.",[13],"Drug: Hypericin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Hypericin","HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.",[9],[27,28],"HyBryte","SGX301",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Jennifer Bonfrisco","CONTACT","609-538-8200","139","jbonfrisco@soligenix.com",[41,54,71,81,91,105,125,145,165,173,183,200,216,235,245,264,280],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":32},"Medical Dermatology Specialists","COMPLETED","Phoenix","Arizona","85006","United States",{"type":49,"coordinates":50},"Point",[51,52],-112.07404,33.44838,{"lat":52,"lon":51},{"facility":55,"status":56,"city":57,"state":45,"zip":58,"country":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Mayo Clinic","RECRUITING","Scottsdale","85259",{"type":49,"coordinates":60},[61,62],-111.89903,33.50921,{"lat":62,"lon":61},[65,68],{"name":66,"role":36,"phone":67,"phoneExt":32,"email":32},"Clinical Trials Referral 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Yang","314-273-3737","yang983@wustl.edu",{"name":141,"role":36,"phone":142,"phoneExt":32,"email":143},"Amy Musiek, MD","314-362-8171","amusiek@wustl.edu",{"name":141,"role":70,"phone":32,"phoneExt":32,"email":32},{"facility":146,"status":56,"city":147,"state":148,"zip":149,"country":47,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Rochester Skin Lymphoma Medical Group","Fairport","New York","14450",{"type":49,"coordinates":151},[152,153],-77.44194,43.09867,{"lat":153,"lon":152},[156,160,164],{"name":157,"role":36,"phone":158,"phoneExt":32,"email":159},"Lily Hauschildt","585 364-1188","lhauschildt@roclymphoma.com",{"name":161,"role":36,"phone":162,"phoneExt":32,"email":163},"Brian Poligone, MD, PhD","585-364-2075","bpoligone@roclymphoma.com",{"name":161,"role":70,"phone":32,"phoneExt":32,"email":32},{"facility":166,"status":43,"city":148,"state":148,"zip":167,"country":47,"cosmosGeoPoint":168,"geoPoint":172,"contacts":32},"Columbia University Medical Center","10032",{"type":49,"coordinates":169},[170,171],-74.00597,40.71427,{"lat":171,"lon":170},{"facility":174,"status":43,"city":175,"state":176,"zip":177,"country":47,"cosmosGeoPoint":178,"geoPoint":182,"contacts":32},"Accellacare (PMG)","Wilmington","North Carolina","28411",{"type":49,"coordinates":179},[180,181],-77.94604,34.23556,{"lat":181,"lon":180},{"facility":184,"status":56,"city":185,"state":186,"zip":187,"country":47,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Penn State Health Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":49,"coordinates":189},[190,191],-76.65025,40.28592,{"lat":191,"lon":190},[194,198],{"name":195,"role":36,"phone":196,"phoneExt":32,"email":197},"Dermatology Clinical Trials Office","717-531-5136","dermatologyclinicaltrial@pennstatehealth.psu.edu",{"name":199,"role":70,"phone":32,"phoneExt":32,"email":32},"Christopher Bazewicz, MD",{"facility":201,"status":56,"city":202,"state":186,"zip":203,"country":47,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Hospital of the University of Pennsylvania","Philadelphia","19104",{"type":49,"coordinates":205},[206,207],-75.16362,39.95238,{"lat":207,"lon":206},[210,214],{"name":211,"role":36,"phone":212,"phoneExt":32,"email":213},"Laura Cesar","445-800-6538","laura.cesar@pennmedicine.upenn.edu",{"name":215,"role":70,"phone":32,"phoneExt":32,"email":32},"Ellen Kim, MD",{"facility":217,"status":56,"city":218,"state":186,"zip":219,"country":47,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"University of Pittsburgh Medical Center","Pittsburgh","15213",{"type":49,"coordinates":221},[222,223],-79.99589,40.44062,{"lat":223,"lon":222},[226,230,234],{"name":227,"role":36,"phone":228,"phoneExt":32,"email":229},"David Liotta","412-864-3681","liottada3@upmc.edu",{"name":231,"role":36,"phone":232,"phoneExt":32,"email":233},"Oleg Akilov, MD, PhD","412 864-3717","akilovoe@upmc.edu",{"name":231,"role":70,"phone":32,"phoneExt":32,"email":32},{"facility":236,"status":43,"city":237,"state":238,"zip":239,"country":47,"cosmosGeoPoint":240,"geoPoint":244,"contacts":32},"Vanderbilt University","Nashville","Tennessee","37212",{"type":49,"coordinates":241},[242,243],-86.78444,36.16589,{"lat":243,"lon":242},{"facility":246,"status":56,"city":247,"state":248,"zip":249,"country":47,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"MD Anderson","Houston","Texas","77030",{"type":49,"coordinates":251},[252,253],-95.36327,29.76328,{"lat":253,"lon":252},[256,260,263],{"name":257,"role":36,"phone":258,"phoneExt":32,"email":259},"Alda Ashu","713-792-1280","abmiraso@mdanderson.org",{"name":261,"role":36,"phone":32,"phoneExt":32,"email":262},"Auris Huen, MD","aohuen@mdanderson.org",{"name":261,"role":70,"phone":32,"phoneExt":32,"email":32},{"facility":265,"status":56,"city":266,"state":248,"zip":267,"country":47,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Austin Institute for Clinical Research","Pflugerville","78660",{"type":49,"coordinates":269},[270,271],-97.62,30.43937,{"lat":271,"lon":270},[274,278],{"name":275,"role":36,"phone":276,"phoneExt":32,"email":277},"Tommy Ha","512-279-2545","tha@atxresearch.com",{"name":279,"role":70,"phone":32,"phoneExt":32,"email":32},"Edward Lain, MD",{"facility":281,"status":56,"city":282,"state":283,"zip":284,"country":47,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Inova Schar Cancer Institute","Fairfax","Virginia","22031",{"type":49,"coordinates":286},[287,288],-77.30637,38.84622,{"lat":288,"lon":287},[291,295],{"name":292,"role":36,"phone":293,"phoneExt":32,"email":294},"Kelly Jeffords","703-970-6548","Kelly.Jeffords@inova.org",{"name":296,"role":70,"phone":32,"phoneExt":32,"email":32},"Jennifer DeSimone, MD",{"type":298,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100552235",false,"NCT06470451","Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL","A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)","FLASH2","Inclusion Criteria:\n\n* Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.\n* Patients with a minimum of three (3) evaluable, discrete lesions.\n* Patients willing to follow the clinical protocol and voluntarily give their written informed consent.\n* Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.\n\nExclusion Criteria:\n\n* History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.\n* History of allergy or hypersensitivity to any of the components of HyBryte.\n* A Screening ECG with a QT interval \\>470 ms (corrected for heart rate using the Fridericia's formula).\n* All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.\n* Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.\n* Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.\n* Patients who have received electron beam irradiation within 3 months of enrollment.\n* Patients with a history of significant systemic immunosuppression.\n* Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.\n* Patients whose condition is spontaneously improving.\n* Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).\n* Patients with extensive skin disease (\\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.\n* Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.\n* Prior participation in the current study.","ALL","18 Years",{"count":309,"type":310},80,"ESTIMATED","INTERVENTIONAL",[313],"PHASE3","To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch\u002Fplaque phase cutaneous T-cell lymphoma (mycosis fungoides).",[316,317,318,319],"CTCL\u002F Mycosis Fungoides","CTCL","Mycosis Fungoides","Cutaneous T Cell Lymphoma","2026-03-30",{"date":322,"type":323},"2026-04-03","ACTUAL",{"date":325,"type":323},"2025-01-07",{"date":327,"type":310},"2026-10",{"name":5,"class":6},17]