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

Condition(s) targeted: Actinic Keratosis

Intervention: Imiquimod Cream, 3.75% (Drug); Zyclara® (Drug); Vehicle of Test Product (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Teva Pharmaceuticals USA

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.

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome: Primary Efficacy Endpoint

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Radiant Research, Inc., Tucson, Arizona 85710, United States; Recruiting
Deborah Callon, Phone: 520-885-6793

Encino Research Center, Encino, California 91436, United States; Recruiting
Maria Celeste Pascual, Phone: 818-788-5060

Dermatology Research Associates, Los Angeles, California 90045, United States; Recruiting
Wendy Hulsopple, Phone: 310-337-7171

Northern California Research, Sacramento, California 95821, United States; Recruiting
Hana Ghannam, CRC, Phone: 916-484-0500

Skin Surgery Medical Group, Inc., San Diego, California 92117, United States; Recruiting
Alisa Schweikl, RN, Phone: 858-292-8641

Longmont Clinic, PC, Longmont, Colorado 80501, United States; Recruiting
Jo Rhoads, Phone: 303-776-8718

Visions Clinical Research, Boynton Beach, Florida 33472, United States; Recruiting
Stephanie Fenwick, Phone: 561-964-7880

Tampa Bay Medical Research, Clearwater, Florida 33761, United States; Recruiting
Kim Stopnytsky, Phone: 727-724-3316

Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States; Not yet recruiting

International Dermatology Research, Inc., Miami, Florida 33144, United States; Recruiting
Fabio Azevedo, Phone: 305-225-0400

Tory Sullivan, M.D., P.A., N. Miami Beach, Florida 33162, United States; Recruiting
Yessenia Roman, Phone: 305-652-8600

Park Avenue Dermatology, PA, Orange Park, Florida 32073, United States; Recruiting
Yvonne Douglas, Phone: 904-541-0315

Leavitt Medical Associates of Florida dba Ameriderm Research, Ormond Beach, Florida 32174, United States; Recruiting
Sandra Warrington Davis, Phone: 386-523-0768

Radiant Research, Inc., Pinellas Park, Florida 33781, United States; Recruiting
Ida Gonzalez, CRC, Phone: 727-544-6367

MedaPhase, Inc., Newnan, Georgia 30263, United States; Not yet recruiting

Altman Dermatology Associates, Arlington Heights, Illinois 60005, United States; Recruiting
Ursula Cholewa, Phone: 847-392-5440

The Indiana Clinical Trials Center, Plainfield, Indiana 46168, United States; Recruiting
Stephen Eads, Phone: 317-838-6082

Dermatology Specialists Research LLC, Louisville, Kentucky 40202, United States; Recruiting
Misty Humphress, Phone: 502-583-7546

Radiant Research, Inc., Cincinnati, Ohio 45249, United States; Recruiting
Nancy Cipollone, Phone: 513-247-5598

Oregon Medical Research Center, PC, Portland, Oregon 97223, United States; Recruiting
Jennifer Logan, Phone: 503-245-1525

Philadelphia Institute of Dermatology, Fort Washington, Pennsylvania 19034, United States; Recruiting
Donna Keenan, Phone: 215-836-7900

Omega Medical Research, Warwick, Rhode Island 02886, United States; Recruiting
Joy Geer, RN, Phone: 401-739-9350

Research Across America, Dallas, Texas 75234, United States; Not yet recruiting

Starting date: September 2012
Last updated: November 9, 2012