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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01413763
First received: August 9, 2011
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: Imiquimod cream 3.75%
Drug: Placebo cream
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Change in 24-hour supraventricular beat count [ Time Frame: Day 14 of each treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time) [ Time Frame: Day 14 of each treatment period ] [ Designated as safety issue: Yes ]
  • Change in 24-hour mean heart rate [ Time Frame: Day 14 of each treatment period ] [ Designated as safety issue: Yes ]
  • Change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts [ Time Frame: Day 14 of each treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Imiquimod cream Drug: Imiquimod cream 3.75%
3.75% cream, applied daily for 2 weeks
Placebo Comparator: Placebo cream Drug: Placebo cream
placebo cream applied daily for 2 weeks

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413763

Locations
United States, Florida
Comprehensive Phase One
Fort Meyers, Florida, United States, 33901
Sponsors and Collaborators
Medicis Global Service Corporation
Investigators
Study Director: Robert W Babilon, MS, MBA Graceway Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01413763     History of Changes
Other Study ID Numbers: GW01-1001
Study First Received: August 9, 2011
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicis Global Service Corporation:
Actinic keratosis
Atrial ectopy

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 22, 2014