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

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicis Global Service Corporation
• Treatments: Imiquimod

Criteria

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