Status:
UNKNOWN
Potential Effect of Topical Imiquimod on Atrial Ectopy in Patients With Actinic Keratosis
Lead Sponsor:
Medicis Global Service Corporation
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed 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 kerat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01413763
Start Date
July 1 2011
End Date
April 1 2013
Last Update
October 25 2012
Active Locations (1)
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1
Comprehensive Phase One
Fort Meyers, Florida, United States, 33901