Morton CA, et al. - Experts ascertained noninferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared with MAL (a cream containing methyl aminolaevulinate) in the treatment of nonaggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT). Findings suggested a high effectiveness and good tolerability of the treatment of nonaggressive BCC with BF-200 ALA-PDT with proven noninferiority to MAL-PDT. After 1 year of follow-up, low recurrence rates were seen.

Methods

• A randomized, phase III trial was performed in Germany and the U.K. with ongoing 5-year follow-up.
• Out of 281 randomized patients, authors treated 138 with BF-200 ALA and 143 with MAL.
• Two PDT sessions were administered in patients 1 week apart.
• Twelve weeks after the second PDT, the remaining lesions were retreated.
• They performed illumination with a red light source (635 nm, 37 J cm^-2).
• Clinical end points and patients’ reassessment were included in the results 12 months after the last PDT.
• They registered this study with EudraCT (number 2013-003241-42).

Results

• Findings suggested that out of the BF-200 ALA-treated patients, 93·4% were complete responders vs 91·8% in the MAL group.
• As per data, 1·6 was the difference of means, with a one-sided 97·5% confidence interval of -6·5, establishing noninferiority (P < 0·0001).
• Experts noted the results for secondary efficacy parameters to be in line with the primary outcome.
• Twelve months after the last treatment, recurrence rates were ≤10%.