Actinic KeratosisPhase 4NCT01413763
Potential Effect of Topical Imiquimod on Atrial Ectopy in Patients With Actinic Keratosis
A Phase 4 study testing Imiquimod cream 3.75% in people with Actinic Keratosis, run by Medicis Global Service Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Imiquimod cream 3.75%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read 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 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.
- Conditions
- Actinic Keratosis
- Being tested
- Imiquimod cream 3.75%, Placebo cream
- Keywords
- Actinic keratosis, Atrial ectopy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod cream 3.75%Drug
3.75% cream, applied daily for 2 weeks
Placebo creamDrug
placebo cream applied daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod cream | Active comparator | Not described Receives: Drug: Imiquimod cream 3.75% |
| Placebo cream | Placebo comparator | Not described Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour supraventricular beat count
Measured: Day 14 of each treatment period
Secondary outcomes (3)
Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time)
Measured: Day 14 of each treatment period
Change in 24-hour mean heart rate
Measured: Day 14 of each treatment period
Change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts
Measured: Day 14 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert W Babilon, MS, MBA, Study director, Graceway Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413763
- Sponsor's protocol ID
- GW01-1001
- Status last verified
- Oct 2012
- First submitted
- 9 Aug 2011
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01413763
- Acronym / sponsor ID
- GW01-1001
- Conditions
- Actinic Keratosis
- Keywords
- Actinic keratosis, Atrial ectopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imiquimod cream | Active comparator | Drug: Imiquimod cream 3.75% |
| Placebo cream | Placebo comparator | Drug: Placebo cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod cream 3.75%3.75% cream, applied daily for 2 weeks | Drug | Imiquimod cream |
| Placebo creamplacebo cream applied daily for 2 weeks | Drug | Placebo cream |
Primary outcome
Change in 24-hour supraventricular beat count
Time frame: Day 14 of each treatment period
3 secondary outcomes
Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time)
Time frame: Day 14 of each treatment period
Change in 24-hour mean heart rate
Time frame: Day 14 of each treatment period
Change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts
Time frame: Day 14 of each treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Babilon, MS, MBA study director
Graceway Pharmaceuticals, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod cream 3.75% in people with Actinic Keratosis, run by Medicis Global Service Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour supraventricular beat count (time frame: Day 14 of each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.