Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Generic Fluorouracil Cream; Carac® (Fluorouracil) Cream; Vehicle Cream
Intervention description: Topical cream, generic formulation of the brand product.; Topical cream, brand product.; Topical cream, placebo. Has no active ingredient.
Intervention MeSH terms: Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil
      0.5% cream against the brand product (Carac) in participants with actinic keratoses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is male and/or female, 18 years of age or older.

          -  Participant is willing and able to give written informed consent.

          -  Participant 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.

          -  Participant has a clinical diagnosis of actinic keratoses with at least 5 and no more
             than 10 clinically typical, visible or palpable, discrete, actinic keratoses (AK)
             lesions, each at least 4 millimeters (mm) in diameter on the face (excluding ears) or
             balding scalp.

          -  Participant 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 participant 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:

          -  Participant is pregnant, lactating, or is planning to become pregnant during the
             study.

          -  Participant is currently enrolled in an investigational drug or device study.

          -  Participant has used an investigational drug or investigational device treatment
             within 30 days prior to the Baseline Visit.

          -  Participant has hyperkeratotic, hypertrophic, or large mat-like AK lesions (for
             example, an AK lesion >1 cm^2 in size) within the treatment area.

          -  Participant has the need or plans to be exposed to artificial tanning devices or
             excessive sunlight during the study.

          -  Participant is immunosuppressed (for example, human immunodeficiency virus (HIV),
             systemic malignancy, graft host disease)

          -  Participant has experienced an unsuccessful outcome from previous topical fluorouracil
             therapy (an unsuccessful outcome is defined as after a reasonable therapeutic study
             with no compliance issues and the topical drug did not work).

          -  Participant has a history of sensitivity to any of the ingredients in the test
             articles.

          -  Participant has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

          -  Participant used topical creams, lotions, or gels of any kind within the selected
             treatment area within 1 day prior to entry into the study.

          -  Participant has used topical medications; corticosteroids, alpha hydroxy acids (for
             example, glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid
             >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate; or
             prescription retinoids (for example, tazarotene, adapalene, tretinoin) within the
             selected treatment area (face or balding scalp) within 1 month prior to the Baseline
             Visit.

          -  Participant has had cryodestruction, curettage, photodynamic therapy, surgical
             excision, or other treatments for AK within the selected treatment area (face or
             balding scalp) within 1 month prior to the Baseline Visit.

          -  Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs,
             immunomodulators, immunosuppressive therapies, or retinoids within 1 month prior to
             the Baseline Visit.

          -  Participant 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 6
             months prior to the Baseline Visit.

          -  Participant 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).

          -  Participant 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.

          -  Participant has any condition which, in the Investigator's opinion, would make it
             unsafe or preclude the participant's ability to fully participate in this research
             study.

          -  Participant is unable to communicate or cooperate with the Investigator due to
             language problems, poor mental development, impaired cerebral function, or physical
             limitations.

          -  Participant is known to be noncompliant or is unlikely to comply with the requirements
             of the study protocol (for example, due to alcoholism, drug dependency, mental
             incapacity) in the opinion of the Investigator.

          -  Participant has been previously enrolled in the same study.