Superficial Basal Cell Carcinoma Clinical Trial
Official title:
Randomized Pilot Study of Treatment for Basal Cell Carcinoma Using the Multiplex 595/1064 nm Laser
Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish
to or cannot tolerate other treatment 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. 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. The control group will visit
the clinic with the same schedule as the treatment group for monitoring of the lesion. All
patients will return one month after last treatment session or clinical visit, for evaluation
of clinical and histological clearance.
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.
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