Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: imiquimod; Aldara™; Vehicle Cream
Intervention description: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks; 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks; Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
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: 462.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratoses; imiquimod; therapeutic equivalence; bioequivalence

Summary:

      At the end of the study, safety and efficacy outcome measures will be compared to determine
      a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently
      marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in
      comparison to the Vehicle cream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were male or non-pregnant females, 18 years of age or older, in generally
             good health. Females who were post-menopausal, surgically sterile or using a medically
             acceptable form of birth control with a negative urine pregnancy test at the Baseline
             visit.

          -  Subjects provided written and verbal informed consent.

          -  Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete
             nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment
             Area on the face and/or anterior scalp.

          -  Subjects were willing and able to comply with study instructions and return to the
             clinic for required visits.

        Exclusion Criteria:

          -  Subjects who were lactating, or planning to become pregnant during the study.

          -  Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2
             Treatment Area.

          -  Subjects who had the need or were planning to be exposed to artificial tanning devices
             or excessive sunlight during the trial.

          -  Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host
             disease, etc.).

          -  Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.

          -  Subjects with known hypersensitivity or previous allergic reaction to any of the
             active or inactive components of the study drugs.

          -  Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic
             therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod,
             diclofenac sodium or other treatments for AK or photodamage.

          -  Subjects who used the following systemic, oral or topical therapies for the periods
             specified prior to entry into the study:

        Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial
        topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic
        acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea -
        greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the
        face and/or anterior scalp.

        Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.

        Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens,
        immunotherapy, or retinoids.