A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose (Fluence) in Subjects with Port-wine Birthmarks Treated with Hemoporfin Photodynamic Therapy

Hematoporphyrin monomethyl ether photodynamic therapy (HMME-PDT) has successfully treated thousands of Chinese patients with Port wine birthmarks (PWB). However, HMME (photosensitizer) is only authorized in China and is not available in other countries. The FDA approved the performance of a Phase Ⅱ Clinical trial in the United States to evaluate the efficacy and safety of PWB patients. Eligible patients with PWB will receive HMME PDT or vehicle PDT at a fixed drug dose and different light fluence. As of December 31, 2024, one patient has been enrolled. Six centers have initiated enrollment. HMME-PDT holds significant potential for development, not only in China but possibly on a global scale.