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

A Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study to Assess the Potential Effect of Topically Applied Imiquimod Cream on Atrial Ectopy in Patients With Actinic Keratosis

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.

Study Overview

• Status: Unknown
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Imiquimod cream 3.75%; Drug: Placebo cream

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Meyers, Florida, United States, 33901
      • Comprehensive Phase One

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Imiquimod cream	Drug: Imiquimod cream 3.75%; 3.75% cream, applied daily for 2 weeks
Placebo Comparator: Placebo cream	Drug: Placebo cream; placebo cream applied daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 24-hour supraventricular beat count	Day 14 of each treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time)	Day 14 of each treatment period
Change in 24-hour mean heart rate	Day 14 of each treatment period
Change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts	Day 14 of each treatment period

Collaborators and Investigators

• Sponsor: Medicis Global Service Corporation
• Investigators: Study Director: Robert W Babilon, MS, MBA, Graceway Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): October 25, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Actinic keratosis; Atrial ectopy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: GW01-1001