Silicon phthalocyanine (Pc 4) photodynamic therapy is a safe modality for cutaneous neoplasms: results of a phase 1 clinical trial

ED Baron, CL Malbasa… - Lasers in surgery …, 2010 - Wiley Online Library
ED Baron, CL Malbasa, D Santo‐Domingo, P Fu, JD Miller, KK Hanneman, AH Hsia…
Lasers in surgery and medicine, 2010Wiley Online Library
Background Photodynamic therapy (PDT) is a non‐invasive treatment for non‐melanoma
skin cancer. However, PDT systems currently used clinically have limitations such as pain
and superficial tissue penetration. The silicon phthalocyanine Pc 4 is a second‐generation
photosensitizer with peak absorption in the far red at 675 nm. Objective To assess the safety
and tolerability of topically applied Pc 4 followed by red light (Pc 4‐PDT) in treating
cutaneous neoplasms. Study Design/Materials and Methods Forty three adults with a …
Background
Photodynamic therapy (PDT) is a non‐invasive treatment for non‐melanoma skin cancer. However, PDT systems currently used clinically have limitations such as pain and superficial tissue penetration. The silicon phthalocyanine Pc 4 is a second‐generation photosensitizer with peak absorption in the far red at 675 nm.
Objective
To assess the safety and tolerability of topically applied Pc 4 followed by red light (Pc 4‐PDT) in treating cutaneous neoplasms.
Study Design/Materials and Methods
Forty three adults with a diagnosis of neoplasms including actinic keratoses, Bowen's disease, squamous cell carcinoma, basal cell carcinoma, or mycosis fungoides were treated with a single administration of Pc 4‐PDT and followed for 14 days. The study utilized a light and Pc 4 dose escalation design in sequential groups of three subjects each.
Results
Pc 4‐PDT was well tolerated with no significant local toxicity or increased photosensitivity. It has promising biologic effects, particularly in mycosis fungoides where 14 of 35 subjects demonstrated a clinical response, which correlates with Pc 4‐PDT‐induced apoptosis, as measured by increased active caspase‐3 in the treated skin lesions.
Conclusions
Pc 4‐PDT is a safe and tolerable treatment modality that effectively triggers apoptosis in cutaneous neoplasms such as mycosis fungoides. Lasers Surg. Med. 42:888–895, 2010. © 2010 Wiley‐Liss, Inc.
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