- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01686152
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
November 6, 2020 updated by: Teva Pharmaceuticals USA
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis of the Face or Balding Scalp
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp.
It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
589
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85710
- Radiant Research, Inc.
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California
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Encino, California, United States, 91436
- Encino Research Center
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Los Angeles, California, United States, 90045
- Dermatology Research Associates
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Sacramento, California, United States, 95821
- Northern California Research
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San Diego, California, United States, 92117
- Skin Surgery Medical Group, Inc.
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Colorado
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Longmont, Colorado, United States, 80501
- Longmont Clinic, PC
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Florida
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Boynton Beach, Florida, United States, 33472
- Visions Clinical Research
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Clearwater, Florida, United States, 33761
- Tampa Bay Medical Research
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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Miami, Florida, United States, 33144
- International Dermatology Research, Inc.
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North Miami Beach, Florida, United States, 33162
- Tory Sullivan, M.D., P.A.
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Orange Park, Florida, United States, 32073
- Park Avenue Dermatology, PA
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Ormond Beach, Florida, United States, 32174
- Leavitt Medical Associates of Florida dba Ameriderm Research
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Pinellas Park, Florida, United States, 33781
- Radiant Research, Inc.
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Georgia
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Newnan, Georgia, United States, 30263
- MedaPhase, Inc.
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Altman Dermatology Associates
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Indiana
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Plainfield, Indiana, United States, 46168
- The Indiana Clinical Trials Center
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Kentucky
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Louisville, Kentucky, United States, 40202
- Dermatology Specialists Research LLC
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Ohio
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Cincinnati, Ohio, United States, 45249
- Radiant Research, Inc.
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Oregon
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Portland, Oregon, United States, 97223
- Oregon Medical Research Center, Pc
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Pennsylvania
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Fort Washington, Pennsylvania, United States, 19034
- Philadelphia Institute of Dermatology
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Omega Medical Research
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Texas
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Dallas, Texas, United States, 75234
- Research Across America
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing and able to provide written informed consent for the study
- 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:
- Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the treatment area of either the face or balding scalp.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Investigational Test Product
Imiquimod Cream, 3.75% (Teva)
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Active Comparator: Reference Listed Drug
Zyclara® (imiquimod Cream), 3.75% (Medicis)
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Other Names:
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Placebo Comparator: Vehicle
Vehicle of Test Product (Teva)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Success/Failure at Visit 5/Week 14
Time Frame: 14 Weeks
|
The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment).
Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
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14 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
September 12, 2012
First Submitted That Met QC Criteria
September 12, 2012
First Posted (Estimate)
September 17, 2012
Study Record Updates
Last Update Posted (Actual)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 6, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYM 2012-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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