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Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01686152
Recruitment Status : Completed
First Posted : September 17, 2012
Last Update Posted : December 6, 2013
Information provided by (Responsible Party):
Teva Pharmaceuticals USA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Imiquimod Cream, 3.75% Drug: Zyclara® Other: Vehicle of Test Product Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 589 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: 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
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Investigational Test Product
Imiquimod Cream, 3.75% (Teva)
Drug: Imiquimod Cream, 3.75%
Active Comparator: Reference Listed Drug
Zyclara® (imiquimod Cream), 3.75% (Medicis)
Drug: Zyclara®
Other Name: Imiquimod Cream (generic name)

Placebo Comparator: Vehicle
Vehicle of Test Product (Teva)
Other: Vehicle of Test Product

Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01686152

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United States, Arizona
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
United States, California
Encino Research Center
Encino, California, United States, 91436
Dermatology Research Associates
Los Angeles, California, United States, 90045
Northern California Research
Sacramento, California, United States, 95821
Skin Surgery Medical Group, Inc.
San Diego, California, United States, 92117
United States, Colorado
Longmont Clinic, PC
Longmont, Colorado, United States, 80501
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
Tory Sullivan, M.D., P.A.
N. Miami Beach, Florida, United States, 33162
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach, Florida, United States, 32174
Radiant Research, Inc.
Pinellas Park, Florida, United States, 33781
United States, Georgia
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
United States, Indiana
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Kentucky
Dermatology Specialists Research LLC
Louisville, Kentucky, United States, 40202
United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45249
United States, Oregon
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
United States, Pennsylvania
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Sponsors and Collaborators
Teva Pharmaceuticals USA

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Responsible Party: Teva Pharmaceuticals USA Identifier: NCT01686152     History of Changes
Other Study ID Numbers: SYM 2012-01
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers