Clinical trial NCT02120898: A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 2.5% and Zyclara® (Imiquimod) Cream, 2.5% in Subjects With Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Imiquimod
Zyclara
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study it so compare the safety and efficacy profiles of a generic imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of actinic keratosis (AK).

Detailed description: Aldara® (imiquimod) Cream, 5% was the first imiquimod product approved by the Food and Drug Administration (FDA) for the topical treatment of AK, superficial basal cell carcinoma and external genital and perianal warts. The FDA approved regimen for the treatment of AK is application of 250 milligrams (mg) of cream twice a week for 16 weeks to a 25 square centimeters (cm\^2) area. In 2011, a lower strength imiquimod cream, Zyclara (imiquimod) Cream, 2.5% was approved by the FDA. When used for the treatment of AK, Zyclara is applied for a shorter duration and in an expanded treatment area (for example, face or scalp) in comparison to Aldara®. This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s). Marketed by Medicis, Zyclara® (imiquimod) cream 2.5% is a safe and effective topical therapy for the treatment of AK of the face and scalp. Actavis has developed a generic formulation of imiquimod 2.5% cream and the current study is designed to evaluate the safety and efficacy of this formulation.

Eligibility criteria: Inclusion Criteria:

* Participant is a male or female, 18 years of age or older.
* Participant has provided written informed consent.
* Participant is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
* Participant has a clinical diagnosis of AK with at least 5 and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4 millimeters (mm) in diameter, in an area greater than 25 cm\^2 on the face (excluding ears) or balding scalp, but not both.
* Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation.
* Females must be post-menopausal, surgically sterile or use an effective method of birth control, with a negative urine pregnancy test (UPT) at the Baseline visit.

Exclusion Criteria:

* Participant is pregnant, lactating, or is planning to become pregnant during the study.
* Participant has hyperkeratotic, hypertrophic or atypical AKs (for example, AK greater than \[\>\] 1 cm\^2 in size) in the treatment area.
* Participant is currently enrolled in an investigational drug or device study.
* Participant plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
* Participant is immunosuppressed (for example; human immunodeficiency virus \[HIV\], systemic malignancy, graft vs. host disease, etc.).
* Participant has experienced an unsuccessful outcome from previous imiquimod therapy (an unsuccessful outcome is defined as after a reasonable therapeutic trial with no compliance issues and the topical drug do not work).
* Participant has used an investigational drug or investigational device within 30 days prior to the Baseline visit.
* Participant has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline visit.
* Participant has cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for AK on the designated treatment area (face or scalp) within 1 month prior to the Baseline visit.
* Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within 1 month prior to the Baseline visit.
* Participant has used topical medications; corticosteroids, alpha hydroxyl acids (for example; glycolic acid, lactic acid etc. \>5%), beta hydroxy acid (salicylic acid \>2%), urea \>5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate or prescription retinoids (for example; tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline visit.
* Participant has used topical creams, lotions or gels of any kind to the selected treatment area within one day prior to the Baseline visit.
* Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or scalp).
* Participant has a history of sensitivity to any of the ingredients in the test articles.
* Participant has any skin pathology or condition (for example; facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could interfere with the evaluation of the test article, worsen due to the treatment or requires the use of interfering topical, systemic or surgical therapy.
* Participant has any condition which, in the investigator's opinion, would make it unsafe or precludes the participant's ability to fully participate in this research study.
* Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example; due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Primary outcomes:
measure: Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population
timeFrame: Week 14
measure: Complete Clearance Rate - Percentage of Participants With Treatment Success: ITT Population
timeFrame: Week 14
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to Week 14
measure: Number of Participants With Local Skin Reactions
timeFrame: Baseline (Day 1) up to Week 14
Other outcomes:
measure: Percentage of Drug Compliance
timeFrame: Baseline (Day 1) up to Week 6
Locations:
city: Birmingham
country: United States
facility: Site 1
state: Alabama
city: Fremont
country: United States
facility: Site 10
state: California
city: Los Angeles
country: United States
facility: Site 8
state: California
city: Denver
country: United States
facility: Site 24
state: Colorado
city: Boca Raton
country: United States
facility: Site 28
state: Florida
city: Brandon
country: United States
facility: Site 26
state: Florida
city: Brandon
country: United States
facility: Site 27
state: Florida
city: Boise
country: United States
facility: Site 21
state: Idaho
city: Arlington Heights
country: United States
facility: Site 3
state: Illinois
city: Champaign
country: United States
facility: Site 17
state: Illinois
city: Carmel
country: United States
facility: Site 7
state: Indiana
city: Indianapolis
country: United States
facility: Site 15
state: Indiana
city: Plainfield
country: United States
facility: Site 22
state: Indiana
city: South Bend
country: United States
facility: Site 23
state: Indiana
city: Clinton Township
country: United States
facility: Site 16
state: Michigan
city: Fridley
country: United States
facility: Site 13
state: Minnesota
city: Albuquerque
country: United States
facility: Site 9
state: New Mexico
city: High Point
country: United States
facility: Site 4
state: North Carolina
city: Wilmington
country: United States
facility: Site 11
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 18
state: North Carolina
city: Portland
country: United States
facility: Site 25
state: Oregon
city: Fountain Inn
country: United States
facility: Site 20
state: South Carolina
city: Knoxville
country: United States
facility: Site 6
state: Tennessee
city: Nashville
country: United States
facility: Site 5
state: Tennessee
city: Austin
country: United States
facility: Site 14
state: Texas
city: College Station
country: United States
facility: Site 12
state: Texas
city: Houston
country: United States
facility: Site 2
state: Texas
Study officials:
affiliation: Actavis Inc.
name: Study Director
role: STUDY_DIRECTOR
References: