Actinic Keratosis Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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