A pilot study of a new methyl aminolevulinate (MAL) photodynamic therapy (PDT) device for at-home treatment of basal cell carcinoma (BCC) showed efficacy comparable to in-clinic treatment and significantly reduced pain levels. These findings were presented at the 30th European Academy of Dermatology and Venereology (EADV) on Oct. 1, 2021. A press release about the presentation notes that PDT for low-risk BCC is well-established as an effective treatment. However, it is associated with significant pain and typically requires two clinic visits, a week apart, for 1.5 to 2 hours each. The development of the new device was spurred by a desire to reduce the pain patients experience during the treatment and to eliminate the need for long clinic visits. Brazil-based dermatologist Dr. Ana Gabriela Salvio, lead author of the study, said in the release: “The importance of a portable PDT device is crucial in its country of origin, Brazil, where many patients need to travel more than 300 km to receive specialized dermatological treatment. However, the global pandemic accelerated the need to develop this at-home treatment element, which has the potential to impact the treatment of BCC internationally.” A total of 15 patients with BCC participated in the pilot study at Amaral Carvalho Hospital together with Sao Carlos Institute of Physics, in Sao Paulo State, Brazil. The first PDT session was performed at the hospital where a 20% MAL cream was applied to the BCC lesion, which was then illuminated for 20 minutes with a commercial red light LED device. Immediately after the first illumination, a light layer of cream was applied and the new portable irradiation device—the size of a coin—was fixed to the skin using medical adhesive tape. The patient was then sent home and advised to turn on the illumination after 1.5 hours and turn it off after 2 hours. The investigators assessed the patients' pain every three minutes during the hospital PDT treatment session and the patients self-reported their pain every 20 minutes during home treatment. The pain was recorded on a numerical scale from 0 to 10. The median score values were compared between hospital and home treatments. Histological analysis of the lesions showed 86.67% clearance 30 days after the PDT, which the authors say is similar to standard PDT treatment. The patients' pain scores were also significantly lower for the PDT treatment performed at home compared to the hospital treatment. “Our study results could have a hugely positive impact on the treatment of basal cell carcinoma in Brazil and the rest of the world,” said Dr. Salvio. “Patients reporting much lower levels of pain from the at-home treatment is really encouraging, especially because it does not come at the cost of efficacy.” Following the success of the pilot study, a clinical trial with more than 200 participants has been approved. The new portable device is also in the process of being patented.
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