Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actavis Inc.; Actavis Mid-Atlantic LLC
• Treatments: Imiquimod

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.