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 study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
281
1 country
1
Study Start
January 28, 2014
Actual (reported)Primary Completion
November 17, 2015
Actual (reported)Study Completion
September 9, 2020
Actual (reported)The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 9, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2014
Actual (reported)February 20, 2014
Actual (reported)May 21, 2014
Actual (reported)November 17, 2015
Actual (reported)March 11, 2019
Actual (reported)September 9, 2020
Actual (reported)Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT
Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.
12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Lesion Complete Response Assessed 12 Weeks After the Last PDT
12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline
12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Patient Complete Response 12 Weeks After PDT-2
12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Patient Recurrence Rate (Overall, Cumulative)
6, 12, 24, 36 and 60 months post-PDT
Lesion Recurrence Rate (Cumulative)
6, 12, 24, 36 and 60 months post-PDT
Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.
Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.
Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
Klinikum Vest GmbH
Recklinghausen, Westfalen-Lippe, 45657, Germany
Morton CA, Dominicus R, Radny P, Dirschka T, Hauschild A, Reinhold U, Aschoff R, Ulrich M, Keohane S, Ekanayake-Bohlig S, Ibbotson S, Ostendorf R, Berking C, Grone D, Schulze HJ, Ockenfels HM, Jasnoch V, Kurzen H, Sebastian M, Stege H, Staubach P, Gupta G, Hubinger F, Ziabreva I, Schmitz B, Gertzmann A, Lubbert H, Szeimies RM. A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF-200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive basal cell carcinoma with photodynamic therapy. Br J Dermatol. 2018 Aug;179(2):309-319. doi: 10.1111/bjd.16441. Epub 2018 May 16.
Rolf M. Szeimies, Prof. Dr.
Klinik fuer Dermatologie und Allergologie (Klinikum Vest - Knappschaftskrankenhaus), Recklinghausen, Germany
Colin Morton, Dr.
Dermatology Department, Stirling Community Hospital, NHS Forth Valley, United Kingdom
281 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2014
First Posted
May 21, 2014
Study Start
January 28, 2014
Actual (reported)Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 17, 2015
Actual (reported)Study Completion
September 9, 2020
Actual (reported)Last Updated
November 3, 2022
Results First Posted
March 11, 2019
Record last verified: 2022-10
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Source: ClinicalTrials.gov.
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