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Potential Effect of Topical Imiquimod on Atrial Ectopy in Patients With Actinic Keratosis

NCT ID: NCT01413763

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to determine the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. The primary endpoint is the change in the 24-hour supraventricular premature beat count. The secondary endpoint is the change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts.

Detailed Description

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This study is a double-blind, randomized, placebo-controlled, 2-way crossover study designed to assess the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. Candidates for study participation will begin screening procedures up to 28 days prior to enrollment. Qualified subjects shall be admitted to the CRU on Day -1 for baseline evaluations and will be randomized to one of two possible treatment sequences. Each subject will receive both the active 3.75% imiquimod cream and the matching placebo in a randomized crossover fashion with a 2-week washout in between each treatment. The application area is the entire face (exclusive of nares, vermilion, periocular areas and ears) or balding scalp. Atrial ectopy will be monitored for 24 hours at Baseline (Day -1; prior to the first dose of study medication), and at the conclusion of each 14-day treatment period using a continuous 12-lead digital Holter recorder.

Adverse events, concomitant medication use, study medication accountability, and subject compliance will be reviewed at each visit.

Conditions

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Actinic Keratosis

Keywords

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Actinic keratosis Atrial ectopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Imiquimod cream

Group Type ACTIVE_COMPARATOR

Imiquimod cream 3.75%

Intervention Type DRUG

3.75% cream, applied daily for 2 weeks

Placebo cream

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type DRUG

placebo cream applied daily for 2 weeks

Interventions

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Imiquimod cream 3.75%

3.75% cream, applied daily for 2 weeks

Intervention Type DRUG

Placebo cream

placebo cream applied daily for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female AK patients with at least 5 typical visible or palpable AK lesions on face or balding scalp
* AK patients in otherwise good general health age 18 years and above
* Female subjects of childbearing potential must be non-pregnant and non-lactating

Exclusion Criteria

* Previous clinical study participation within 30 days (drug or device)
* Evidence of clinically significant diseases
* History of drug or alcohol abuse
* Subjects with uncontrolled systemic hypertension, NYHA heart failure classification Class \> II, or a history of atrial fibrillation or atrial flutter
* Subjects using imiquimod or interferon within 30 days prior to the first dose of study medication
* Have known allergies to any excipient in the study cream
* Have melanoma anywhere on the body
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert W Babilon, MS, MBA

Role: STUDY_DIRECTOR

Graceway Pharmaceuticals, LLC

Locations

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Comprehensive Phase One

Fort Meyers, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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GW01-1001

Identifier Type: -

Identifier Source: org_study_id