Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study.

Summary

In a pivotal multicenter RCT, red light PDT with 10% ALA gel achieved 75.9% histologic and 83.4% clinical clearance in superficial BCC versus 19.0% and 21.4% with vehicle. Safety was acceptable and 88.1% of patients rated cosmetic outcomes as good/very good; long-term durability is under follow-up.

Key Findings

• Histologic clearance 75.9% with 10% ALA-PDT vs 19.0% with vehicle (P<.0001).
• Clinical clearance 83.4% with 10% ALA-PDT vs 21.4% with vehicle (P<.0001).
• 88.1% of patients rated cosmetic outcome as very good or good; no new safety signals.
• Few face/scalp lesions enrolled; 60-month follow-up ongoing.

Clinical Implications

ALA-PDT can be considered for superficial BCC when cosmetic preservation is prioritized or surgery is contraindicated; clinicians should counsel on potential need for retreatment and pending long-term recurrence data.

Limitations

• Limited enrollment of face/scalp lesions limits generalizability to cosmetically critical sites.
• Long-term recurrence outcomes not yet available (ongoing 60-month follow-up).

Future Directions

Report 5-year clearance/recurrence, compare head-to-head with surgery and topical therapies (e.g., imiquimod), and evaluate outcomes specifically in facial/scalp lesions.