Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatme⦠(NCT03573401) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of BF-200 ALA (AmeluzĀ®) and BF-RhodoLEDĀ® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
United States187 participantsStarted 2018-09-25
Plain-language summary
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication AmeluzĀ® performed with the PDT-lamp BF-RhodoLEDĀ® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures.
* Men or women ā„18 years of age.
* Presence of ā„1 naĆÆve sBCC lesion in the treatment areas face/forehead, bald scalp, extremities and/or neck/trunk, all of which are, according to the clinical judgement of the investigator, likely to be histologically confirmed as sBCCs. Lesions should not be within the embryonic fusion planes (H-zone), especially within 2 cm of the hair zone or on the ears. In case of multiple lesions, one lesion is defined as Main Target Lesion which will be excised at the end of the clinical observation period. Only eligible naĆÆve sBCCs, confirmed by histology taken at screening, are allowed to be included in the study as Main or Additional Target Lesions. Thus, eligible sBCCs must lack any histological evidence of aggressive growth patterns (e.g. severe squamous metaplasia, infiltrative/desmoplastic features or basosquamous features). BCCs assessed as non-naĆÆve (e.g. previously treated or recurrent) or non-eligible by biopsy taken at screening (and in a distance \>5 cm from the next lesion included in the study) should be excised by surgery or removed by cryotherapy in a timely manner. Other treatments for these lesions are not allowed during the study.
* The diameter ā¦
What they're measuring
1
Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion.
Timeframe: 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion