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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID: NCT01413763
Run by: Medicis Global Service Corporation
People needed: 50
Starts: 2011-07-01
Expected to finish: 2013-04-01
Last updated by the study team: 2012-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Comprehensive Phase One — Fort Meyers, Florida, United States

Full record on ClinicalTrials.gov

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