A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
NCT ID: NCT01502020
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
410 participants
INTERVENTIONAL
2011-02-28
2011-11-30
Brief Summary
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The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Zyclara™
imiquimod cream, 3.75%
Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
Generic Imiquimod Cream, 3.75%
imiquimod cream, 3.75%
Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
Vehicle Cream
Vehicle Cream
Dosage form: Topical Cream Dosage: Placebo Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
Interventions
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Vehicle Cream
Dosage form: Topical Cream Dosage: Placebo Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
imiquimod cream, 3.75%
Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
imiquimod cream, 3.75%
Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
Eligibility Criteria
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Inclusion Criteria
* Subject provided written informed consent.
* Subject was willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
* Subject had a clinical diagnosis of actinic keratoses (AK) with at least five (5) and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4mm in diameter, in an area greater than 25cm2 on the face (excluding ears) or balding scalp, but not both.
* Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
* If subject was a woman of childbearing potential (WOCBP), she must have had a negative urine pregnancy test (UPT) and agreed to use an effective form of birth control for the duration of the study (e.g., abstinence, stabilized on hormonal contraceptives for at least three months \[oral, implant, injection, IUD, patch or NuvaRing\] condom and spermicidal or diaphragm and spermicidal). Abstinence was an acceptable form of birth control for subjects who were not sexually active. Subjects who became sexually active during the trial had to agree to use an effective, non-prohibited form of birth control for the duration of the study.
Exclusion Criteria
* Subjects had hyperkeratotic, hypertrophic or atypical AKs (e.g., AK \> 1 cm2 in size) in the Treatment Area.
* Subject was enrolled in an investigational drug or device study during the study period.
* Subject was planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
* Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
* Subject had experienced an unsuccessful outcome from previous imiquimod therapy (An unsuccessful outcome was defined as after a reasonable therapeutic trial with no compliance issues, topical application did not work).
* Subject had used an investigational drug or investigational device within 30 days prior to the Baseline Visit.
* Subject had laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline Visit.
* Subject had cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for actinic keratosis on the face or scalp within one month prior to the Baseline Visit.
* Subject had used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within one month prior to the Baseline Visit.
* Subject had used topical medications, corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. \> 5%), beta hydroxy acid (salicylic acid \> 2%), urea \>5%, 5-fluorouracil, diclofenac, imiquimod or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline Visit.
* Subject had used topical creams, lotions or gels of any kind to the selected Treatment Area within one day prior to the Baseline Visit.
* Subject had a basal cell or squamous cell carcinoma within the Treatment Area within one year of study enrollment.
* Subject had a history of sensitivity to any of the ingredients in the test articles.
* Subject had any skin pathology or condition (e.g., facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could have interfered with the evaluation of the test article, worsened due to the treatment or required the use of interfering topical, systemic or surgical therapy.
* Subject had any condition which, in the investigator's opinion, would have made it unsafe or precluded the subject's ability to fully participate in the research study.
* Subject was known to be noncompliant or was unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
18 Years
ALL
No
Sponsors
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Actavis Mid-Atlantic LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Piacquadio, M.D.
Role: STUDY_DIRECTOR
Therapeutics, Inc.
Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
International Dermatology Research, Inc.
Miami, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Indiana Clinical Trials Center
Plainfield, Indiana, United States
Dermatology Specialists
Louisville, Kentucky, United States
Michigan Center for Research Corp.
Clinton Township, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Skin Specialists, P.C.
Omaha, Nebraska, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology, Laser & Vein Specialists of the Carolinas,
Charlotte, North Carolina, United States
Dermatology Research Center of Cincinnati
Cincinnati, Ohio, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States
DermResearch, Inc.
Austin, Texas, United States
Suzanne Bruce and Associates, P.A.
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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094-3152-301
Identifier Type: -
Identifier Source: org_study_id