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Actinic KeratosisPhase 3NCT02120898

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

A Phase 3 study testing Imiquimod and Zyclara® in people with Actinic Keratosis, run by Actavis Inc. at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratosis
What is being tested?
Imiquimod and Zyclara®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
467 participants
Where
27 sitesUnited States
Study dates
10 Oct 2013to 30 Apr 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Site 9

    Albuquerque, New Mexico, 87106

  • Site 3

    Arlington Heights, Illinois, 60005

  • Site 14

    Austin, Texas, 78759

  • Site 1

    Birmingham, Alabama, 35025

  • Site 28

    Boca Raton, Florida, 33486

  • Site 21

    Boise, Idaho, 83704

  • Site 26

    Brandon, Florida, 33511

  • Site 27

    Brandon, Florida, 33511

  • Site 7

    Carmel, Indiana, 46032

  • Site 17

    Champaign, Illinois, 61820

  • Site 16

    Clinton Township, Michigan, 48038

  • Site 12

    College Station, Texas, 77845

  • Site 24

    Denver, Colorado, 80220

  • Site 20

    Fountain Inn, South Carolina, 29644

  • Site 10

    Fremont, California, 94538

  • Site 13

    Fridley, Minnesota, 55432

  • Site 4

    High Point, North Carolina, 27262

  • Site 2

    Houston, Texas, 77056

  • Site 15

    Indianapolis, Indiana, 46256

  • Site 6

    Knoxville, Tennessee, 37917

  • Site 8

    Los Angeles, California, 90045

  • Site 5

    Nashville, Tennessee, 37203

  • Site 22

    Plainfield, Indiana, 46168

  • Site 25

    Portland, Oregon, 97223

  • Site 23

    South Bend, Indiana, 46617

  • Site 11

    Wilmington, North Carolina, 28403

  • Site 18

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Imiquimod, Zyclara®, Vehicle Cream
Keywords
Actinic Keratosis, Imiquimod, Zyclara
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImiquimodDrug

    Cream, generic formulation of the brand product.

  • Zyclara®Drug

    Cream, brand product.

  • Vehicle CreamDrug

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

Study groups in NCT02120898
Study groupRoleWhat they receive
Generic Imiquimod Cream 2.5%ExperimentalGeneric 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.
Receives: Drug: Imiquimod
Zyclara® (Imiquimod) Cream 2.5%Active comparatorZyclara® (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.
Receives: Drug: Zyclara®
Vehicle CreamPlacebo comparatorVehicle 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.
Receives: Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 14

  2. 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.

    Measured: Week 14

Secondary outcomes (2)

  1. Number of Participants With Adverse Events (AEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Mild AEs: awareness of sign or symptom, but easily tolerated. Moderate AEs: discomfort sufficient to cause interference with normal activities. Severe AEs: inability to carry out usual activities. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Measured: Baseline (Day 1) up to Week 14

  2. Number of Participants With Local Skin Reactions

    Local skin reactions included erythema, flaking/scaling/dryness, scabbing/crusting, pruritus, erosion/ulceration, pain, edema, and weeping/exudate. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Measured: Baseline (Day 1) up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2014 (estimated)
  2. Study start10 Oct 2013
  3. Primary completion30 Apr 2014
  4. Study completion30 Apr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120898
Sponsor's protocol ID
094-3153-301
Status last verified
Nov 2019
First submitted
21 Apr 2014
Last updated
13 Dec 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imiquimod and Zyclara® in people with Actinic Keratosis, run by Actavis Inc. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population (time frame: Week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02120898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.

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