{"entity":{"id":"nct02448381","kind":"trial","name":"FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)","aka":[],"tldr":"A phase 3 trial of Synthetic hypericin in Cutaneous T-cell lymphoma, run by Soligenix, completed.","summary":"FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) is a phase 3 interventional study registered as NCT02448381 by Soligenix, with 169 participants recorded, started 2015-12 and reaching its primary completion in 2020-06. Interventions recorded: SGX301 (synthetic hypericin), Placebo. Conditions recorded: Cutaneous T-Cell Lymphoma.\n\nLinked to the drug Synthetic hypericin because the registry names it among its interventions and Cutaneous T-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02448381","url":"https://clinicaltrials.gov/study/NCT02448381"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hypericin-sgx301"],"companies":["soligenix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02448381","phase":"3","setting":"A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma","sponsor":"Soligenix","started":"2015-12","startedType":"actual","yearReported":2022,"enrolled":169,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo, Responder","primary":true,"unit":"participants","arms":[{"name":"SGX301","n":116,"value":19,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-04-15), not from a publication"},{"name":"Placebo","n":50,"value":2}],"p":"0.04","source":"https://clinicaltrials.gov/study/NCT02448381?tab=results"}]},"route":"/trials/nct02448381/","neighbours":{"cancer":[{"id":"cutaneous-t-cell-lymphoma","kind":"cancer","name":"Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome)","route":"/cancers/cutaneous-t-cell-lymphoma/"}],"drug":[{"id":"hypericin-sgx301","kind":"drug","name":"Synthetic hypericin","route":"/drugs/hypericin-sgx301/"}],"company":[{"id":"soligenix","kind":"company","name":"Soligenix","route":"/companies/soligenix/"}]}}