Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser

Basal cell carcinoma is a malignancy with significant prevalence that rarely metastasizes but
can be locally destructive. Laser therapy for this type of lesion may be a superior option
for patients who do not wish to or cannot tolerate other modalities such as topical
chemotherapeutics or surgery.

In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm
Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm
in size. Eligible patients with biopsy-proven superficial or nodular BCCs less than 1.5 cm in
size will have the opportunity to enroll in this study. This is an unblinded study in which
patients will be randomized to either a treatment arm or a control arm. Patients in the
treatment arm will receive three treatments with the 595/1064 nm multiplex laser spaced four
weeks apart. In addition to assessing the presence of any adverse effects, photographs will
be taken at each visit. One month after the last treatment session, patients in this group
will return for evaluation of 1) clinical clearance and 2) histological clearance of their
BCC. In order to assess clinical clearance, a dermatologist will grossly examine, measure,
and document any residual lesion. Afterwards, a deep excisional biopsy encompassing the
entire region will be taken and histological clearance will be determined by a microscopic
examination for any residual tumor cells. Follow-up for wound care of the biopsy will occur
one week later. Tumor burden will be calculated by change in surface area of the lesion.

After standard diagnostic biopsy, patients in the control arm will be followed for three
regular visits, spaced 4 weeks apart. One month after the third follow-up visit, control
patients will return for final photography and evaluation of clinical and histological
clearance, just as the treatment arm. Although extremely rare1, if any clinical signs of
progression are visible during this period (what we will consider greater than 10% growth),
the patient will be withdrawn from the study and will undergo standard of care treatment.

Inclusion Criteria:

- Adults age 18 years or older

- Diagnostic biopsy must be no later than three months prior to enrollment

- Lesion is biopsy-proven nodular or superficial BCC

- BCC is 1.5 cm or less in diameter

- BCC is on trunk or extremities

- Fitzpatrick skin types I, II, III, or IV

- If female, must no longer be of child-bearing potential

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- BCC is greater than 1.5 cm in size

- If location of BCC is on the face.

- Patients whose biopsy shows a subtype other than superficial or nodular, or has
characteristics of a more aggressive nature, such as: Basosquamous basal cell
carcinoma, Morpheaform/ infiltrative basal cell carcinoma, Sclerosing basal cell
carcinoma, Recurrent basal cell carcinomas

- Patients who may not be able to tolerate light therapy, such as: Patients with seizure
disorders triggered by light, Patients who have or are currently receiving gold
therapy, Patients with any light sensitive disorder, Patients taking medication that
increases sensitivity to light, Patients with Systemic Lupus Erythematous

- Fitzpatrick skin types V or VI

- Patients who are taking certain oral medications such as: Anticoagulants except for
aspirin 81 mg, Isotretinoin (currently or within last 6 months), Medications that
alter wound healing

- Patients who have a history of Herpes Simplex Virus outbreak in the area to be treated

- Patients whose lesion has been previously, or is currently being, treated by another
modality (topical immunomodulators/ chemotherapeutics, cryotherapy, curettage and
electrodesiccation, surgical excision, or Mohs micrographic surgery)