Overview

This trial is active, not recruiting.

Condition actinic keratosis
Treatments imiquimod cream 3.75%, placebo cream
Phase phase 4
Sponsor Medicis Global Service Corporation
Start date July 2011
End date April 2013
Trial size 50 participants
Trial identifier NCT01413763, GW01-1001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Active Comparator)
imiquimod cream 3.75%
3.75% cream, applied daily for 2 weeks
(Placebo Comparator)
placebo cream
placebo cream applied daily for 2 weeks

Primary Outcomes

Measure
Change in 24-hour supraventricular beat count
time frame: Day 14 of each treatment period

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Medicis Global Service Corporation.