A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses

NCT ID: NCT02120898

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2014-04-30

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.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; Imiquimod; Zyclara

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Generic Imiquimod Cream 2.5%

Generic imiquimod cream 2.5% will be applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants will apply test article for 14 consecutive days for each treatment cycle.

Group Type: EXPERIMENTAL

Imiquimod

Intervention Type: DRUG

Cream, generic formulation of the brand product.

Zyclara® (Imiquimod) Cream 2.5%

Zyclara® (imiquimod) cream 2.5% will be applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants will apply test article for 14 consecutive days for each treatment cycle.

Group Type: ACTIVE_COMPARATOR

Zyclara®

Intervention Type: DRUG

Cream, brand product.

Vehicle Cream

Vehicle cream will be applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants will apply test article for 14 consecutive days for each treatment cycle.

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.

Interventions

Imiquimod

Cream, generic formulation of the brand product.

Intervention Type: DRUG

Zyclara®

Cream, brand product.

Intervention Type: DRUG

Vehicle Cream

Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Actavis Inc.

Locations

Site 1

Birmingham, Alabama, United States

Site 10

Fremont, California, United States

Site 8

Los Angeles, California, United States

Site 24

Denver, Colorado, United States

Site 28

Boca Raton, Florida, United States

Site 26

Brandon, Florida, United States

Site 27

Brandon, Florida, United States

Site 21

Boise, Idaho, United States

Site 3

Arlington Heights, Illinois, United States

Site 17

Champaign, Illinois, United States

Site 7

Carmel, Indiana, United States

Site 15

Indianapolis, Indiana, United States

Site 22

Plainfield, Indiana, United States

Site 23

South Bend, Indiana, United States

Site 16

Clinton Township, Michigan, United States

Site 13

Fridley, Minnesota, United States

Site 9

Albuquerque, New Mexico, United States

Site 4

High Point, North Carolina, United States

Site 11

Wilmington, North Carolina, United States

Site 18

Winston-Salem, North Carolina, United States

Site 25

Portland, Oregon, United States

Site 20

Fountain Inn, South Carolina, United States

Site 6

Knoxville, Tennessee, United States

Site 5

Nashville, Tennessee, United States

Site 14

Austin, Texas, United States

Site 12

College Station, Texas, United States

Site 2

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

094-3153-301

Identifier Type: -

Identifier Source: org_study_id