Clinical trial NCT01686152: Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2012-09-17
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment Success/Failure at Visit 5/Week 14
timeFrame: 14 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: Longmont
country: United States
facility: Longmont Clinic, PC
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, M.D., P.A.
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida dba Ameriderm Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research LLC
state: Kentucky
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Dallas
country: United States
facility: Research Across America
state: Texas
Study officials:
References: