Photodynamic therapy gains FDA approval for superficial BCC
Phase 3 trial data showed greater clinical and histological clearance than with placebo photodynamic therapy.
By
Kathryn Wighton
September 15, 2026
Clinical Scorecard: Photodynamic therapy gains FDA approval for superficial BCC
At a Glance
Category Detail
Condition Superficial Basal Cell Carcinoma (BCC) Key Mechanisms Aminolevulinic acid hydrochloride (Ameluz) topical gel combined with photodynamic therapy using BF-RhodoLED lamp. Target Population Adults with superficial basal cell carcinoma. Care Setting Dermatology clinics and outpatient settings.
Key Highlights
FDA approved Ameluz for superficial BCC treatment. Approximately 3.6 million BCC cases diagnosed annually in the US. Superficial BCC accounts for 15% to 20% of BCC cases. Phase 3 trial showed 66% clinical response with Ameluz vs. 5% with placebo. Application-site reactions were the most common adverse effects. Guideline-Based Recommendations
Diagnosis
Histological confirmation of superficial BCC is required. Management
Use of aminolevulinic acid hydrochloride with photodynamic therapy for treatment. Monitoring & Follow-up
Assess clinical and histological response at 12 weeks post-treatment. Risks
Application-site reactions consistent with the therapy’s safety profile. Patient & Prescribing Data
Adults with superficial BCC, particularly those with multiple lesions or in cosmetically sensitive areas.
Ameluz is the first FDA-approved photodynamic therapy for skin cancer.
Clinical Best Practices
Consider photodynamic therapy for patients who prefer non-surgical options. Monitor for application-site reactions during treatment. Related Resources & Content
