Clinical trial · Interventional
Potential Effect of Topical Imiquimod on Atrial Ectopy in Patients With Actinic Keratosis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod cream 3.75% | Drug | Imiquimod | ALIAS |
| Placebo cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Imiquimod cream
- interventionNames
- Drug: Imiquimod cream 3.75%
- type
- PLACEBO_COMPARATOR
- label
- Placebo cream
- interventionNames
- Drug: Placebo cream
Primary outcomes (1)
- measure
- Change in 24-hour supraventricular beat count
- timeFrame
- Day 14 of each treatment period
Secondary outcomes (3)
- measure
- Change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available