The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with
the medication Ameluz performed with the PDT-lamp BF-RhodoLED in comparison to the
respective placebo treatment for superficial basal cell carcinoma (BCC).
The study will be conducted as randomized, double blind and vehicle-controlled ( 4:1 ratio of
verum (BF-200 ALA; Ameluz) to vehicle (placebo)) clinical trial at 15 sites in the United
States of America (US). Each site should randomize between 10 and 20 subjects.
Each subject will complete a clinical observation period that will last for up to 7 months
(up to 4 weeks screening and pre-randomization period, and up to 6 months clinical
observation period) followed by a 5-year follow-up (FU) period after the completion of the
first PDT cycle.
The treatment of superficial BCC lesion(s) comprises of up to two PDT cycles each with two
PDT sessions one to two weeks apart of each other. 12 weeks after the first PDT of the first
cycle lesion(s) will be assessed clinically and only subjects with remaining BCC lesion(s)
will be retreated in the second PDT cycle starting the same day. For clinically completely
cleared subjects the clinical observation period of the study will end and these subjects
will enter the FU part of the study.
For each subject a Main Target Lesion will be defined that will be excised either 12 weeks
after the first PDT of the first cycle, if clinically cleared, or at the end of the clinical
observation period in order to histologically confirm the clinical assessment. Additional
Target Lesions will be assessed clinically, only. Randomization will be stratified by the
number of lesions (1 vs 2 Lesion(s)).
Definitions of complete responders comprise of:
Complete response of the Main Target Lesion which is assessed 12 weeks after the start
of the last PDT cycle that included treatment of the Main Target Lesion and is defined
as a Main Target Lesion that is completely clinically and histologically cleared.
In general, clinically complete responders are categorized 12 weeks after the start of
the last PDT cycle according to clinical assessment only and are defined as subjects
with all lesions (Main plus Additional Target Lesions) clinically cleared.
Verum and vehicle are indistinguishable. However, treatment is accompanied with typical
adverse events (AEs). In order to guarantee the blind status of the investigator assessing
efficacy after each PDT cycle, a second investigator or delegated person will perform drug
application and light treatment as well as all safety evaluations at visits where PDT is
applied and during the phone call 1 week after each PDT cycle, respectively. Both
investigators (delegated person(s)) are not entitled to exchange information about the study
outcome and side effects.
Superficial Basal Cell Carcinoma
Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT),
Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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