{"entity":{"id":"nct02144077","kind":"trial","name":"Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy","aka":[],"tldr":"A phase 3 trial of Aminolevulinic acid and Methyl aminolevulinate in Basal cell carcinoma, run by Biofrontera Bioscience GmbH, completed.","summary":"Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy is a phase 3 interventional study registered as NCT02144077 by Biofrontera Bioscience GmbH, with 281 participants recorded, started 2014-01-28 and reaching its primary completion in 2015-11-17. Interventions recorded: BF-200 ALA, methyl-aminolevulinate. Conditions recorded: Basal Cell Carcinoma (BCC).\n\nLinked to the drug Methyl aminolevulinate because the registry names it among its interventions and Basal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02144077","url":"https://clinicaltrials.gov/study/NCT02144077"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["aminolevulinic-acid","methyl-aminolevulinate"],"companies":["biofrontera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02144077","phase":"3","setting":"A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)","sponsor":"Biofrontera Bioscience GmbH","started":"2014-01-28","startedType":"actual","yearReported":2019,"enrolled":281,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT","primary":true,"unit":"%","arms":[{"name":"BF-200 ALA","n":121,"value":93.4,"note":"95% CI 87.0 to 96.9; Figures from the ClinicalTrials.gov results section (first posted 2019-03-11), not from a publication"},{"name":"Methyl-aminolevulinate","n":110,"value":91.8,"note":"95% CI 84.6 to 96.0"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02144077?tab=results"}]},"route":"/trials/nct02144077/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"}],"drug":[{"id":"aminolevulinic-acid","kind":"drug","name":"Aminolevulinic acid (topical, for photodynamic therapy)","route":"/drugs/aminolevulinic-acid/"},{"id":"methyl-aminolevulinate","kind":"drug","name":"Methyl aminolevulinate","route":"/drugs/methyl-aminolevulinate/"}],"company":[{"id":"biofrontera","kind":"company","name":"Biofrontera","route":"/companies/biofrontera/"}]}}