[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552235":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":40,"responsibleParty":298,"collaborators":32,"id":300,"slug":32,"hasResults":301,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":301,"sex":307,"minAge":308,"maxAge":32,"enrollmentInfo":309,"targetDuration":32,"studyType":312,"phases":313,"briefSummary":315,"conditions":316,"keywords":32,"overallStatus":57,"whyStopped":32,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},{"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",[41,55,72,82,92,106,126,146,166,174,184,201,217,236,246,265,281],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":32},"Medical Dermatology Specialists","COMPLETED","Phoenix","Arizona","85006","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-112.07404,33.44838,{"lat":53,"lon":52},{"facility":56,"status":57,"city":58,"state":45,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Mayo 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Carolina","28411",{"type":50,"coordinates":180},[181,182],-77.94604,34.23556,{"lat":182,"lon":181},{"facility":185,"status":57,"city":186,"state":187,"zip":188,"country":47,"countryCode":48,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Penn State Health Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":50,"coordinates":190},[191,192],-76.65025,40.28592,{"lat":192,"lon":191},[195,199],{"name":196,"role":36,"phone":197,"phoneExt":32,"email":198},"Dermatology Clinical Trials Office","717-531-5136","dermatologyclinicaltrial@pennstatehealth.psu.edu",{"name":200,"role":71,"phone":32,"phoneExt":32,"email":32},"Christopher Bazewicz, MD",{"facility":202,"status":57,"city":203,"state":187,"zip":204,"country":47,"countryCode":48,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Hospital of the University of Pennsylvania","Philadelphia","19104",{"type":50,"coordinates":206},[207,208],-75.16362,39.95238,{"lat":208,"lon":207},[211,215],{"name":212,"role":36,"phone":213,"phoneExt":32,"email":214},"Laura Cesar","445-800-6538","laura.cesar@pennmedicine.upenn.edu",{"name":216,"role":71,"phone":32,"phoneExt":32,"email":32},"Ellen Kim, MD",{"facility":218,"status":57,"city":219,"state":187,"zip":220,"country":47,"countryCode":48,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"University of Pittsburgh Medical Center","Pittsburgh","15213",{"type":50,"coordinates":222},[223,224],-79.99589,40.44062,{"lat":224,"lon":223},[227,231,235],{"name":228,"role":36,"phone":229,"phoneExt":32,"email":230},"David Liotta","412-864-3681","liottada3@upmc.edu",{"name":232,"role":36,"phone":233,"phoneExt":32,"email":234},"Oleg Akilov, MD, PhD","412 864-3717","akilovoe@upmc.edu",{"name":232,"role":71,"phone":32,"phoneExt":32,"email":32},{"facility":237,"status":43,"city":238,"state":239,"zip":240,"country":47,"countryCode":48,"cosmosGeoPoint":241,"geoPoint":245,"contacts":32},"Vanderbilt University","Nashville","Tennessee","37212",{"type":50,"coordinates":242},[243,244],-86.78444,36.16589,{"lat":244,"lon":243},{"facility":247,"status":57,"city":248,"state":249,"zip":250,"country":47,"countryCode":48,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"MD Anderson","Houston","Texas","77030",{"type":50,"coordinates":252},[253,254],-95.36327,29.76328,{"lat":254,"lon":253},[257,261,264],{"name":258,"role":36,"phone":259,"phoneExt":32,"email":260},"Alda Ashu","713-792-1280","abmiraso@mdanderson.org",{"name":262,"role":36,"phone":32,"phoneExt":32,"email":263},"Auris Huen, MD","aohuen@mdanderson.org",{"name":262,"role":71,"phone":32,"phoneExt":32,"email":32},{"facility":266,"status":57,"city":267,"state":249,"zip":268,"country":47,"countryCode":48,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Austin Institute for Clinical Research","Pflugerville","78660",{"type":50,"coordinates":270},[271,272],-97.62,30.43937,{"lat":272,"lon":271},[275,279],{"name":276,"role":36,"phone":277,"phoneExt":32,"email":278},"Tommy Ha","512-279-2545","tha@atxresearch.com",{"name":280,"role":71,"phone":32,"phoneExt":32,"email":32},"Edward Lain, MD",{"facility":282,"status":57,"city":283,"state":284,"zip":285,"country":47,"countryCode":48,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Inova Schar Cancer Institute","Fairfax","Virginia","22031",{"type":50,"coordinates":287},[288,289],-77.30637,38.84622,{"lat":289,"lon":288},[292,296],{"name":293,"role":36,"phone":294,"phoneExt":32,"email":295},"Kelly Jeffords","703-970-6548","Kelly.Jeffords@inova.org",{"name":297,"role":71,"phone":32,"phoneExt":32,"email":32},"Jennifer DeSimone, MD",{"type":299,"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":310,"type":311},80,"ESTIMATED","INTERVENTIONAL",[314],"PHASE3","To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch\u002Fplaque phase cutaneous T-cell lymphoma (mycosis fungoides).",[317,318,319,320],"CTCL\u002F Mycosis Fungoides","CTCL","Mycosis Fungoides","Cutaneous T Cell Lymphoma","2026-03-30",{"date":323,"type":324},"2026-04-03","ACTUAL",{"date":326,"type":324},"2025-01-07",{"date":328,"type":311},"2026-10",{"name":5,"class":6},17]