A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Imiquimod; Zyclara®; Vehicle Cream
Intervention description: Cream, generic formulation of the brand product.; Cream, brand product.; Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis; Imiquimod; Zyclara

Summary:

      The purpose of this study it so compare the safety and efficacy profiles of a generic
      imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of
      actinic keratosis (AK).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a male or female, 18 years of age or older.

          -  Participant has provided written informed consent.

          -  Participant is willing and able to apply the test article 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 AK with at least 5 and no more than 20
             clinically typical, visible or palpable AK lesions, each at least 4 millimeters (mm)
             in diameter, in an area greater than 25 cm^2 on the face (excluding ears) or balding
             scalp, but not both.

          -  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 has hyperkeratotic, hypertrophic or atypical AKs (for example, AK greater
             than [>] 1 cm^2 in size) in the treatment area.

          -  Participant is currently enrolled in an investigational drug or device study.

          -  Participant plans to be exposed to artificial tanning devices or excessive sunlight
             during the trial.

          -  Participant is immunosuppressed (for example; human immunodeficiency virus [HIV],
             systemic malignancy, graft vs. host disease, etc.).

          -  Participant has experienced an unsuccessful outcome from previous imiquimod therapy
             (an unsuccessful outcome is defined as after a reasonable therapeutic trial with no
             compliance issues and the topical drug do not work).

          -  Participant has used an investigational drug or investigational device within 30 days
             prior to the Baseline visit.

          -  Participant has had dermatologic procedures or surgeries such as: laser resurfacing,
             PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion
             on the face or balding scalp within 6 months prior to the Baseline visit.

          -  Participant has cryodestruction or chemodestruction, curettage, photodynamic therapy,
             surgical excision or other treatments for AK on the designated treatment area (face or
             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 used topical medications; corticosteroids, alpha hydroxyl 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) to the face or balding scalp
             within one month prior to the Baseline visit.

          -  Participant has used topical creams, lotions or gels of any kind to the selected
             treatment area within one day 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 scalp).

          -  Participant has a history of sensitivity to any of the ingredients in the test
             articles.

          -  Participant has any skin pathology or condition (for example; facial/scalp psoriasis,
             atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could
             interfere with the evaluation of the test article, worsen due to the treatment 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 precludes the participant's ability to fully participate in this research
             study.

          -  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.