A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
- Subject was male or female, 18 years of age or older.
- Subject provided written informed consent.
- Subject was 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.
- Subject had a clinical diagnosis of actinic keratoses (AK) with at least five (5) and
no more than 20 clinically typical, visible or palpable AK lesions, each at least 4mm
in diameter, in an area greater than 25cm2 on the face (excluding ears) or balding
scalp, but not both.
- Subject was in good general health and free of any disease state or physical
condition that might have impaired evaluation of AK lesions or which, in the
investigator's opinion, exposed the subject to an unacceptable risk by study
- If subject was a woman of childbearing potential (WOCBP), she must have had a
negative urine pregnancy test (UPT) and agreed to use an effective form of birth
control for the duration of the study (e.g., abstinence, stabilized on hormonal
contraceptives for at least three months [oral, implant, injection, IUD, patch or
NuvaRing] condom and spermicidal or diaphragm and spermicidal). Abstinence was an
acceptable form of birth control for subjects who were not sexually active. Subjects
who became sexually active during the trial had to agree to use an effective,
non-prohibited form of birth control for the duration of the study.
- Subject was pregnant, lactating, or planning to become pregnant during the study.
- Subjects had hyperkeratotic, hypertrophic or atypical AKs (e.g., AK > 1 cm2 in size)
in the Treatment Area.
- Subject was enrolled in an investigational drug or device study during the study
- Subject was planning to be exposed to artificial tanning devices or excessive
sunlight during the trial.
- Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease,
- Subject had experienced an unsuccessful outcome from previous imiquimod therapy (An
unsuccessful outcome was defined as after a reasonable therapeutic trial with no
compliance issues, topical application did not work).
- Subject had used an investigational drug or investigational device within 30 days
prior to the Baseline Visit.
- Subject had 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.
- Subject had cryodestruction or chemodestruction, curettage, photodynamic therapy,
surgical excision or other treatments for actinic keratosis on the face or scalp
within one month prior to the Baseline Visit.
- Subject had used oral corticosteroid therapy, interferon, cytotoxic drugs,
immunomodulators, immunosuppressive therapies or retinoids within one month prior to
the Baseline Visit.
- Subject had 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 or prescription retinoids (e.g.,
tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior
to the Baseline Visit.
- Subject had used topical creams, lotions or gels of any kind to the selected
Treatment Area within one day prior to the Baseline Visit.
- Subject had a basal cell or squamous cell carcinoma within the Treatment Area within
one year of study enrollment.
- Subject had a history of sensitivity to any of the ingredients in the test articles.
- Subject had any skin pathology or condition (e.g., facial/scalp psoriasis, atopic
dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could have
interfered with the evaluation of the test article, worsened due to the treatment or
required the use of interfering topical, systemic or surgical therapy.
- Subject had any condition which, in the investigator's opinion, would have made it
unsafe or precluded the subject's ability to fully participate in the research study.
- Subject was known to be noncompliant or was 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.