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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01413763
• Other study ID #: GW01-1001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: October 24, 2012
• Start date: July 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2012
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Imiquimod cream 3.75%
3.75% cream, applied daily for 2 weeks
• Placebo cream
placebo cream applied daily for 2 weeks

Locations

Country	Name	City	State
United States	Comprehensive Phase One	Fort Meyers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Global Service Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour supraventricular beat count		Day 14 of each treatment period	Yes
Secondary	Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time)		Day 14 of each treatment period	Yes
Secondary	Change in 24-hour mean heart rate		Day 14 of each treatment period	Yes
Secondary	Change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts		Day 14 of each treatment period	Yes