Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ
Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Age > 18, any gender
- Biopsy proven SCCis without evidence of microinvasion beyond the epidermis
- Low-risk site (trunk, arms, legs)
- Clinical presence of tumor at biopsy site to ensure that biopsy itself was not curative
- Lesion <2cm
- Subject amenable to surgical excision at 6 months after the last PDT treatment
Exclusion Criteria:
- 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
- Exclusion of any patient with primary or secondary immunosuppression
- History of > 6 skin cancers in the past year
- Photosensitizing condition such as lupus
- Sensitivity to porphyrins
Sites / Locations
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Intervention Group
After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.
Subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). Lastly, they will be asked to fill out a satisfaction survey.