This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment
of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for
treating SCCis. This study will also secondarily evaluate the tolerability of using
photodynamic therapy for treatment of SCCis.
Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include
lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to
topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light
(BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin
cancers in the past year, photosensitizing condition such as lupus, or sensitivity to
Age, gender, size, and location of the SCCis will be recorded. All subjects will receive
surgical treatment of their SCCis. The control group will undergo a surgical excision of the
tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The
intervention group will receive PDT plus surgical treatment. Photographs of the lesion will
be taken at each study visit. Subjects in the intervention group will then undergo the study
procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to
the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA
incubation and blue light exposure. At 6 months after the last treatment, subjects in the
intervention group will return for clinical follow-up and surgical excision of the lesion.
After excision, the specimen will be sent for processing by pathology and subjects will be
asked to fill out a satisfaction visual analog scale. All slides will be read by a
board-certified dermatopathologist. Side effects will also be monitored using the same graded
scale described previously. Mild adverse events that have been associated with PDT, including
erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation.
These reactions usually occur during or immediately after the PDT treatment.