Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

This is a multicenter, double-blind, vehicle-controlled, parallel group comparison study of
a generic fluorouracil cream, 0.5% and Carac (fluorouracil) cream, 0.5% in subjects with
actinic keratoses on the full face or balding scalp.

Inclusion Criteria:

- Subject is male and/or female, 18 years of age or older.

- Subject is willing and able to give written informed consent.

- Subject is willing and able to apply the test article(s) as directed, comply with
study instructions and commit to all follow-up visits for the duration of the study.

- Subject has a clinical diagnosis of actinic keratoses with at least five and no more
than ten clinically typical, visible or palpable, discrete, AK lesions, each at least
4 mm in diameter on the face (excluding ears) or balding scalp.

- Subject is in good general health and free of any disease state or physical condition
that might impair evaluation of AK lesions or which, in the investigator's opinion,
exposes the subject to an unacceptable risk by study participation.

- Females must be post-menopausal, surgically sterile, or use an effective method of
birth control with a negative urine pregnancy test (UPT) at the Baseline Visit

Exclusion Criteria:

- Subject is pregnant, lactating, or is planning to become pregnant during the study.

- Subject is currently enrolled in an investigational drug or device study.

- Subject has used an investigational drug or investigational device treatment within
30 days prior to the Baseline Visit.

- Subject has hyperkeratotic, hypertrophic, or large mat-like AKs (e.g., AK >1 cm2 in
size) within the Treatment Area.

- Subject has the need or plans to be exposed to artificial tanning devices or
excessive sunlight during the trial.

- Subject is immunosuppressed (e.g., human immunodeficiency virus (HIV), systemic
malignancy, graft host disease, etc.)

- Subject has experienced an unsuccessful outcome from previous topical fluorouracil
therapy (an unsuccessful outcome is defined as after a reasonable therapeutic trial
with no compliance issues and the topical drug did not work).

- Subject has a history of sensitivity to any of the ingredients in the test articles.

- Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

- Subject used topical creams, lotions, or gels of any kind within the selected
Treatment Area within one day prior to entry into the study.

- Subject has used topical medications; corticosteroids, alpha hydroxy acids (e.g.,
glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea
>5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, or prescription
retinoids (e.g., tazarotene, adapalene, tretinoin) within the selected Treatment Area
(face or balding scalp) within one (1) month prior to the Baseline Visit.

- Subject has had cryodestruction, curettage, photodynamic therapy, surgical excision,
or other treatments for AK within the selected Treatment Area (face or balding scalp)
within one (1) month prior to the Baseline Visit.

- Subject has used oral corticosteroid therapy, interferon, cytotoxic drugs,
immunomodulators, immunosuppressive therapies, or retinoids within one month prior to
the Baseline Visit.

- Subject has had dermatologic procedures or surgeries such as: laser resurfacing,
Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B therapy, chemical peels, or
dermabrasion within the selected Treatment area (face or balding scalp) within six
months prior to the Baseline Visit.

- Subject has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy)
or untreated skin cancers within the selected Treatment Area (face or balding scalp).

- Subject has any skin pathology or condition on the face or balding scalp that, in the
investigator's opinion, could interfere with the evaluation of the test article or
requires the use of interfering topical, systemic, or surgical therapy.

- Subject has any condition which, in the investigator's opinion, would make it unsafe
or preclude the subject's ability to fully participate in this research study.

- Subject is unable to communicate or cooperate with the investigator due to language
problems, poor mental development, impaired cerebral function, or physical
limitations.

- Subject is known to be noncompliant or is unlikely to comply with the requirements of
the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in
the opinion of the investigator.

- Subject has been previously enrolled in the same study.