Actinic Keratoses Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Parallel Group, Vehicle-Controlled Study to Determine the Clinical Equivalence of a Generic Imiquimod Cream, 5% and Aldara™ Cream in Subjects With Actinic Keratosis
NCT number | NCT00948428 |
Other study ID # | D94-3101-07 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | April 2009 |
Verified date | September 2020 |
Source | Actavis Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 462 |
Est. completion date | April 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | DermResearch, Inc. | Austin | Texas |
United States | University Dermatology Consultants, Inc. | Cincinnati | Ohio |
United States | Cherry Creek Research, Inc. | Denver | Colorado |
United States | Deaconess Clinic, Inc. | Evansville | Indiana |
United States | Associates in Research, Inc. | Fresno | California |
United States | Minnesota Clinical Study Center | Fridley | Minnesota |
United States | Burke Pharmaceutical Research | Hot Springs | Arkansas |
United States | Suzanne Bruce & Associates, P.A. | Houston | Texas |
United States | Dermatology Associates of Knoxville, P.C. | Knoxville | Tennessee |
United States | FXM Research Corp. | Miami | Florida |
United States | Tennessee Clinical Research Center | Nashville | Tennessee |
United States | Mt. Sinai School of Medicine | New York | New York |
United States | MedaPhase, Inc. | Newnan | Georgia |
United States | Oregon Medical Research Center, P.C. | Portland | Oregon |
United States | Rhode Island Hospital, Dermatopharmacology Division | Providence | Rhode Island |
United States | Dermatology Research Center, Inc. | Salt Lake City | Utah |
United States | Dermatology Clinical Research Center of San Antonio | San Antonio | Texas |
United States | Skin Surgery Medical Group, Inc. | San Diego | California |
United States | Premier Clinical Research | Spokane | Washington |
United States | Derm Research Center of New York, Inc. | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Actavis Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24) | Week 24 | ||
Secondary | Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16). | Week 16 | ||
Secondary | Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit). | Week 24 |
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