Red Light Therapy with Gel Shows High Clearance Rates for Superficial Basal Cell Carcinoma

 Red light photodynamic therapy (PDT) with 10% aminolevulinic acid (ALA) tamed superficial basal cell carcinoma (BCC) in a phase 3 trial with no new safety concerns.

METHODOLOGY:

• Patients (N = 187) with superficial BCC were treated with red light PDT in a phase 3, multicenter, randomized, double-blind, vehicle-controlled trial at 21 US centers.
• Participants were randomly assigned 4:1 to receive 10% ALA gel or vehicle control.
• The primary endpoint was combined histological and clinical clearance of the main target lesion 12 weeks after the final PDT cycle. 

TAKEAWAY:

• Combined clinical and histological clearance rates of the main target lesions were significantly higher with 10% ALA gel compared with vehicle alone (65.5% vs 4.8%; P < .0001).
• Complete clinical clearance was seen in 82.1% and 21.4% of participants treated with 10% ALA and vehicle, respectively (P < .0001), and 10% vs 4.8% showed complete combined clinical and histological clearance (P < .0001).
• Noncleared lesions in the 10% ALA gel group showed a median size reduction of 41.9%, but vehicle-treated lesions showed no change in size.
• Most patients (88.1%) rated outcomes as very good or good; no death or treatment discontinuation occurred; and adverse events were mild in 62.4% of patients, moderate in 31%, and severe in about 6.2%.

IN PRACTICE:

Significantly higher clearance rates were achieved with 10% ALA than vehicle, with favorable safety and positive esthetic outcome, the authors wrote. “The high efficacy, good tolerability, and cosmetic benefits demonstrated in our study reinforce the value of red light PDT with 10% ALA gel as a highly suitable alternative to surgical excision for the treatment of [superficial] BCC, especially for multiple or large lesions, in low risk areas, or where patients oppose surgery,” they said, adding that PDT has great potential “as an adjunctive therapy to surgical excision, as the burden for patients may be reduced due to removal of less tissue.”

SOURCE:

The study was led by Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, South Carolina, and was published online on August 20 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Few patients had lesions on the face or scalp. Long-term outcomes were not reported because the 60-month follow-up was ongoing.

DISCLOSURES:

The study was funded by Biofrontera Bioscience GmbH, Leverkusen, Germany. Schlesinger disclosed receiving consulting fees and serving as an investigator for AbbVie, Almirall, Biofrontera Bioscience GmbH, Feldan Therapeutics, Galderma, Apogee, Regeneron, SUN Pharma, and Verrica Pharmaceuticals. Other authors also reported receiving consulting, speaker, and investigator fees from various companies, including Biofrontera Bioscience GmbH. One author also reported having employment and stock options with Biofrontera Bioscience GmbH. Additional disclosures are noted in the original article.

https://www.medscape.com/viewarticle/red-light-pdt-ala-gel-shows-high-clearance-rates-superficial-2025a1000mk3