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

Completed · Phase 3

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID

NCT00948428

Run by

Actavis Inc.

People needed

462

Starts

2008-05-01

Expected to finish

2009-04-01

Last updated by the study team

2020-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Associates in Research, Inc. — Fresno, California, United States
• Skin Surgery Medical Group, Inc. — San Diego, California, United States
• Cherry Creek Research, Inc. — Denver, Colorado, United States
• FXM Research Corp. — Miami, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Derm Research Center of New York, Inc. — Stony Brook, New York, United States
• University Dermatology Consultants, Inc. — Cincinnati, Ohio, United States
• Oregon Medical Research Center, P.C. — Portland, Oregon, United States
• Rhode Island Hospital, Dermatopharmacology Division — Providence, Rhode Island, United States
• Dermatology Associates of Knoxville, P.C. — Knoxville, Tennessee, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• DermResearch, Inc. — Austin, Texas, United States
• Suzanne Bruce & Associates, P.A. — Houston, Texas, United States
• Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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