Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)

A Randomized, Double-blind, Phase III, Multi-center Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) Versus Placebo in the Field-directed Treatment of Mild to Moderate Actinic Keratosis With Photodynamic Therapy (PDT) When Using the BF-RhodoLED® Lamp

The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

The study was performed as a randomized, multicentre, double-blind, placebo- controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were screened in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED.

Inclusion Criteria:

• Males or females between 18 and 85 years of age (inclusive)
• Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within 1-2 fields

Exclusion Criteria:

• History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA
• Current treatment with immunosuppressive therapy
• Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)) within the last 4 weeks
• Confirmed diagnosis of SCC for the representative lesion by screening biopsy