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

NCT01413763 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-10-25

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Imiquimod cream 3.75%

3.75% cream, applied daily for 2 weeks

DRUG

Placebo cream

placebo cream applied daily for 2 weeks

Sponsors & Collaborators

  • Medicis Global Service Corporation

    lead INDUSTRY

Principal Investigators

  • Robert W Babilon, MS, MBA · Graceway Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413763 on ClinicalTrials.gov