The study has demonstrated a statistically significant reduction in the number of inflammatory lesions from baseline with the median reduction at three weeks after the final treatment of 37.5% (95% confidence limits of 48.4, and 30.3) for Blu-U (10J/cm2) plus vehicle containing Levulan and 41.7% (95% confidence limits of 56.7, and 29.0) for Blu-U (10J/cm2) plus vehicle without Levulan (p value less than 0.0001).
These positive results persisted or were improved at the six week follow-up. All patients tolerated their treatments well. The study has demonstrated that both treatments were safe and well tolerated with no serious adverse events.
While both groups showed a statistically significant reduction in inflammatory lesions from baseline, the results did not demonstrate a statistically significant difference between the Levulan PDT and control groups. Based on these results, Dusa will not pursue further clinical development of Levulan PDT in combination with Blu-U for moderate to severe acne.
Dusa remains committed to, and will focus its resources on continuing to grow the Levulan PDT franchise for the treatment of Grade 1-2 actinic keratoses (AKs) and pursuing other clinical development projects, such as the treatment of AKs and the prevention of squamous cell carcinomas in solid organ transplant recipients (SOTR). Dusa expects to begin enrollment in the SOTR study by the end of 2008.