Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Imiquimod Cream, 3.75%; Zyclara®; Vehicle of Test Product
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 589.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and
      Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic
      keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy
      of each of the two active treatments is superior to that of the Vehicle cream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent for the study

          -  At least 18 years of age.

          -  Immunocompetent male or non-pregnant and non-lactating female. Each female subject of
             childbearing potential (excluding women who are surgically sterilized or
             postmenopausal for at least 2 years), in addition to having a negative urine pregnancy
             test at Visit 1/Day 1, must be willing to use an acceptable form of birth control
             during the study. For the purpose of this study, the following are considered
             acceptable methods of birth control: oral contraceptives, contraceptive patches,
             contraceptive implant, vaginal contraceptive, double-barrier methods (for example,
             condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device
             (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable
             method of birth control if the subject becomes sexually active. Subjects entering the
             study who are on hormonal contraceptives (oral contraceptives, patches and injection)
             must have been on this method for at least 3 months (90 days) prior to the study and
             continue the method for the duration of the study. Subjects who had used hormonal
             contraception (oral contraceptives, patches and injection) and stopped must have
             stopped no less than 3 months (90 days) prior to baseline. Subjects entering the study
             using contraceptive implants and intrauterine contraceptives must have been on this
             method for at least 6 months (180 days) and continue for the duration of the study and
             if they stopped must have stopped no less than 6 months (180 days) prior to baseline.

          -  Clinical diagnosis of AK, defined as ≥ 5 and ≤ 20 clinically typical, visible or
             palpable AK lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on
             either the face (excluding ears) or balding scalp, but not both face and scalp.

          -  In general good health and free from any clinically significant disease, other than
             AK, that might interfere with the study evaluations.

          -  Willing and able to understand and comply with the requirements of the study, apply
             the IP as instructed, attend the required visits, comply with therapy prohibitions,
             and be able to complete the study.

        Exclusion Criteria:

          -  Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea,
             squamous cell carcinoma, or other possible confounding skin conditions on the
             treatment area of either the face or balding scalp.

          -  Clinically significant systemic disease (immunological deficiencies), unstable medical
             disorder, life-threatening disease, or current malignancies.

          -  Use on the face or balding scalp of chemical peel, dermabrasion, laser abrasion,
             psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the
             last 6 months (180 days)

          -  Use of any systemic cancer chemotherapy medications in the last 6 months (180 days)

          -  Use on the face or balding scalp of cryodestruction or chemodestruction, curettage,
             photodynamic therapy, surgical excision, topical 5-fluorouracil, topical
             corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol,
             or other treatments for AK in the last 1 month (30 days)

          -  Immunomodulators or immunosuppressive therapies, interferon, oral/systemic
             corticosteroids, or cytotoxic drugs in the last 1 month (30 days). Intranasal or
             inhaled corticosteroids are acceptable if kept constant throughout the study.

          -  Need or intent to continue to use any treatment listed in the four points above during
             the current study

          -  Known hypersensitivity or allergies to imiquimod or any component of the IP (in any
             dosage form).

          -  Females who are pregnant, breastfeeding, intending to become pregnant during the
             study, or who do not agree to use an acceptable form of birth control during the
             study.

          -  Any clinically significant condition or situation other than the condition being
             studied that, in the opinion of the investigator, would interfere with the study
             evaluations or optimal participation in the study.

          -  Use of any investigational drug or investigational device within 1 month (30 days)
             prior to randomization.

          -  Previous participation in this study.

          -  Sunburn in the designated treatment area to be treated at study entry.

          -  Current involvement in activities that require excessive or prolonged sun exposure.

          -  Consumption of excessive amounts of alcohol, abuse drugs.