NCT01413763

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

August 9, 2011

Last Update Submit

October 24, 2012

Conditions

Actinic Keratosis

Keywords

Actinic keratosisAtrial ectopy

Outcome Measures

Primary Outcomes (1)

  • Change in 24-hour supraventricular beat count

    Day 14 of each treatment period

Secondary Outcomes (3)

  • Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time)

    Day 14 of each treatment period

  • Change in 24-hour mean heart rate

    Day 14 of each treatment period

  • Change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts

    Day 14 of each treatment period

Study Arms (2)

Imiquimod cream

ACTIVE COMPARATOR
Drug: Imiquimod cream 3.75%

Placebo cream

PLACEBO COMPARATOR
Drug: Placebo cream

Interventions

Imiquimod cream 3.75%DRUG

3.75% cream, applied daily for 2 weeks

Imiquimod cream
Placebo creamDRUG

placebo cream applied daily for 2 weeks

Placebo cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Phase One

Fort Meyers, Florida, 33901, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert W Babilon, MS, MBA

    Graceway Pharmaceuticals, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

US(1)