Inclusion Criteria:

- Patients who are able to understand and willing to give informed consent prior to
study procedures

- Age 18+

- Have one BCC which meets the following criteria: a primary tumor (not recurrent, not
previously biopsied or treated; non-infected; located on the limbs, trunk (anogenital
area excluded), neck, or head. The target tumor must be visible; maximum tumor area
of 1.5 cm in diameter; macroscopically (clinically) consistent with nodular BCC;
nodular subtype, with circumscribed growth pattern; histologically consistent with
nBCC, and having no histological evidence of aggressive growth patterns; easily
identifiable and treatable by subject or reliable subject representative;

- Are willing and able to participate in the study as an outpatient, making necessary
visits to the clinic during the treatment period and comply with study requirements,
including the following: A minimum of 1 and a maximum of 3 prestudy confirmatory
biopsies of different tumors before beginning study drug treatment (each biopsy will
remove no more than 25% of the target tumor); at least 4 or 5 clinic visits during
the study; blood sampling at screening/initiation visit and end of treatment; urine
pregnancy testing for females of childbearing potential at the screening/initiation
visit and the end of treatment visits

- Are free of any significant physical abnormalities at the potential application site
area, which would interfere with assessment of possible site reactions (eg, eczema,
psoriasis, tattoos)

- If female and of childbearing potential, has negative urine pregnancy tests during
screening/initiation visit, and is willing to use a medically acceptable method of
contraception during the treatment period

Exclusion Criteria:

- High-risk areas within 0.5 cm of the eyes

- Have evidence of clinically significant, unstable medical conditions such as
metastatic tumor or tumor with high probability of metastatic spread, cardiovascular
(NYHA class III, IV), immunomodulation or immunosuppressive therapies, hematologic,
hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal

- Have or had other malignant tumors of the skin within the target tumor site or
surrounding area (eg, malignant melanoma, epithelioma spinocellular, squamous cell
carcinoma). The surrounding area includes the skin within 2 cm of the target site
margins in all directions

- Have received the following treatments for any indication in the target tumor site or
surrounding area within the designated time period (6 weeks) before treatment
initiation: Topical retinoids, Topical steroids, Surgical excision, Curettage, Cryo-,
Thermo- or Chemodestruction, Photodynamic therapy, Therapeutic UV-Radiation

- Have received the following systemic treatments within the designated period before
study treatment initiation: Interferon (6 weeks), Immunomodulators or
immunosuppressive therapies (10 weeks), Cytotoxic drugs (6 months), Investigational
drugs (8 weeks), Drugs known to have major organ toxicity (8 weeks), Corticosteroids
(oral or injectable) (6 weeks), Inhaled corticosteroids (>1200 ng/day for
beclomethasone, or >600 ng/day for fluticasone)(4 weeks)

- Have received any systemic cancer chemotherapy within 6 months before study treatment
initiation

- Have known allergies to any excipient in the study cream (isostearic acid, benzyl
alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan monostearate, white
petrolatum, glycerin, methyl paraben, propyl paraben, purified water, and xanthan gum

- Are known to be pregnant or lactating (currently or within the past 3 months). If
the subject was pregnant, at least 3 months must have elapsed since parturition or
termination

- Have any dermatological disease in the target tumor site or surrounding area that may
be exacerbated by treatment with imiquimod or cause difficulty with examination (eg
psoriasis, eczema)

- Are currently or within the past 8 weeks participating in another clinical study

- Have active chemical dependency or alcoholism as assessed by the investigator

- Have had a systemic bacterial or viral infection within 2 weeks prior to study
initiation