Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
NCT ID: NCT01686152
Last Updated: 2020-11-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
589 participants
INTERVENTIONAL
2012-09-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Investigational Test Product
Imiquimod Cream, 3.75% (Teva)
Imiquimod Cream, 3.75%
Reference Listed Drug
Zyclara® (imiquimod Cream), 3.75% (Medicis)
Zyclara®
Vehicle
Vehicle of Test Product (Teva)
Vehicle of Test Product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Imiquimod Cream, 3.75%
Zyclara®
Vehicle of Test Product
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 18 years of age.
* Immunocompetent male or non-pregnant and non-lactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives (oral contraceptives, patches and injection) must have been on this method for at least 3 months (90 days) prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception (oral contraceptives, patches and injection) and stopped must have stopped no less than 3 months (90 days) prior to baseline. Subjects entering the study using contraceptive implants and intrauterine contraceptives must have been on this method for at least 6 months (180 days) and continue for the duration of the study and if they stopped must have stopped no less than 6 months (180 days) prior to baseline.
* Clinical diagnosis of AK, defined as ≥ 5 and ≤ 20 clinically typical, visible or palpable AK lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on either the face (excluding ears) or balding scalp, but not both face and scalp.
* In general good health and free from any clinically significant disease, other than AK, that might interfere with the study evaluations.
* Willing and able to understand and comply with the requirements of the study, apply the IP as instructed, attend the required visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion Criteria
* Clinically significant systemic disease (immunological deficiencies), unstable medical disorder, life-threatening disease, or current malignancies.
* Use on the face or balding scalp of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the last 6 months (180 days)
* Use of any systemic cancer chemotherapy medications in the last 6 months (180 days)
* Use on the face or balding scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol, or other treatments for AK in the last 1 month (30 days)
* Immunomodulators or immunosuppressive therapies, interferon, oral/systemic corticosteroids, or cytotoxic drugs in the last 1 month (30 days). Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study.
* Need or intent to continue to use any treatment listed in the four points above during the current study
* Known hypersensitivity or allergies to imiquimod or any component of the IP (in any dosage form).
* Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
* Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
* Use of any investigational drug or investigational device within 1 month (30 days) prior to randomization.
* Previous participation in this study.
* Sunburn in the designated treatment area to be treated at study entry.
* Current involvement in activities that require excessive or prolonged sun exposure.
* Consumption of excessive amounts of alcohol, abuse drugs.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Pharmaceuticals USA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research, Inc.
Tucson, Arizona, United States
Encino Research Center
Encino, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Northern California Research
Sacramento, California, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
Longmont Clinic, PC
Longmont, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, United States
Park Avenue Dermatology, PA
Orange Park, Florida, United States
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Dermatology Specialists Research LLC
Louisville, Kentucky, United States
Radiant Research, Inc.
Cincinnati, Ohio, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Research Across America
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SYM 2012-01
Identifier Type: -
Identifier Source: org_study_id