Novel drug yields high clearance rate for actinic keratosis in extremities

BF-200 ALA, an investigational drug, elicits high actinic keratoses (AK) clearance rates on the trunk, neck, and extremities when used with red light photodynamic therapy (PDT), a recent study has found.

The phase III study included 50 patients (mean age 70.8 years, 52 percent women) who received both BF-200 ALA and an identical vehicle, each applied as a topical to AK lesions on different sides of the body. All patients also received a maximum of two field-directed PDTs. The primary endpoint was the total lesion clearance rate (TLCR) 12 weeks after the final treatment.

BF-200 ALA cleared 86.0 percent of all lesions 12 weeks after the last PDT treatment, significantly greater than the 32.9-percent TLCR rate in the vehicle-treated side (p<0.0001). Stratifying by baseline characteristics did not change the principal findings.

Secondary efficacy endpoints, such as complete clearance rate per patient side (67.3 percent vs 12.2 percent; p<0.0001) and the histopathologically confirmed lesion response rate per patient (85.1 percent vs 63.8 percent; p=0.0032) further confirmed the significant superiority of BF-200 ALA over vehicle.

The investigational drug was also significantly better at preventing recurrence, with 1-year recurrence rates of 14.1 percent and 27.5 percent for BF-200 ALA and vehicle, respectively (p=0.0068).

In terms of safety, the researchers documented higher rates of treatment-emergent adverse events in the BF-200 ALA-treated AK lesion fields as opposed to vehicle. For example, pain was reported in 100 percent of all BF-200 ALA-treated fields relative to only 40 percent of vehicle-treated fields. A similar pattern was reported for erythema (90.0 percent vs 14.0 percent, pruritus (48.0 percent vs 18.0 percent), oedema (32.0 percent vs 0 percent), and scabs (30.0 percent vs 4.0 percent), among others.