Status:
COMPLETED
Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
Lead Sponsor:
Actavis Inc.
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
A nationwide, multicenter, double-blind, vehicle-controlled parallel group comparison study of a Generic Imiquimod cream, 5% (Actavis Mid-Atlantic LLC) and currently marketed Aldara (imiquimod) cream,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT00948428
Start Date
May 1 2008
End Date
April 1 2009
Last Update
September 4 2020
Active Locations (20)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
Associates in Research, Inc.
Fresno, California, United States, 93720
3
Skin Surgery Medical Group, Inc.
San Diego, California, United States, 92117
4
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209