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

NCT02120898 | Completed Phase 3 Results

• 1 other identifier: 094-3153-301
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 27

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).

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; Imiquimod; Zyclara

Outcome Measures

Primary Outcomes (2)

• Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population

  Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero actinic keratosis (AK) lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - \[ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)\]} \* 100.

  Week 14

• Complete Clearance Rate - Percentage of Participants With Treatment Success: ITT Population

  Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero AK lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - \[ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)\]} \* 100.

  Week 14

Secondary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  Baseline (Day 1) up to Week 14

• Number of Participants With Local Skin Reactions

  Baseline (Day 1) up to Week 14

Other Outcomes (1)

• Percentage of Drug Compliance

  Baseline (Day 1) up to Week 6

Study Arms (3)

Generic Imiquimod Cream 2.5%

EXPERIMENTAL

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.

Drug: Imiquimod

Zyclara® (Imiquimod) Cream 2.5%

ACTIVE COMPARATOR

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.

Drug: Zyclara®

Vehicle Cream

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

Interventions

Imiquimod DRUG

Cream, generic formulation of the brand product.

Generic Imiquimod Cream 2.5%

Zyclara® DRUG

Cream, brand product.

Zyclara® (Imiquimod) Cream 2.5%

Vehicle Cream DRUG

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

Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (27)

Site 1

Birmingham, Alabama, 35025, United States

Location

Site 10

Fremont, California, 94538, United States

Location

Site 8

Los Angeles, California, 90045, United States

Location

Site 24

Denver, Colorado, 80220, United States

Location

Site 28

Boca Raton, Florida, 33486, United States

Location

Site 26

Brandon, Florida, 33511, United States

Location

Site 27

Brandon, Florida, 33511, United States

Location

Site 21

Boise, Idaho, 83704, United States

Location

Site 3

Arlington Heights, Illinois, 60005, United States

Location

Site 17

Champaign, Illinois, 61820, United States

Location

Site 7

Carmel, Indiana, 46032, United States

Location

Site 15

Indianapolis, Indiana, 46256, United States

Location

Site 22

Plainfield, Indiana, 46168, United States

Location

Site 23

South Bend, Indiana, 46617, United States

Location

Site 16

Clinton Township, Michigan, 48038, United States

Location

Site 13

Fridley, Minnesota, 55432, United States

Location

Site 9

Albuquerque, New Mexico, 87106, United States

Location

Site 4

High Point, North Carolina, 27262, United States

Location

Site 11

Wilmington, North Carolina, 28403, United States

Location

Site 18

Winston-Salem, North Carolina, 27103, United States

Location

Site 25

Portland, Oregon, 97223, United States

Location

Site 20

Fountain Inn, South Carolina, 29644, United States

Location

Site 6

Knoxville, Tennessee, 37917, United States

Location

Site 5

Nashville, Tennessee, 37203, United States

Location

Site 14

Austin, Texas, 78759, United States

Location

Site 12

College Station, Texas, 77845, United States

Location

Site 2

Houston, Texas, 77056, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, CE Studies
• Organization: Teva Pharmaceuticals Inc. USA

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Study Director

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: October 10, 2013
• Primary Completion: April 30, 2014
• Study Completion: April 30, 2014
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-11

Locations

US (27)