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NCT03914417 · ClinicalTrials.gov registry record · Phase 2
Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03914417: Completed Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03914417 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03914417, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp. At Day 0, one Actinic Keratosis (AK) in the treatment area had been biopsied via a 3 mm punch. The tissue collected was sent to pathology for confirmatory diagnosis as well as genomic analysis. The remaining AKs had been identified, photographed, and documented on a transparency. One of the remaining AKs was designated as the target lesion. The patient returned to the clinic in 7 days (+/- 3) for suture removal. Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14). At week 14, a biopsy via a 3 mm punch was done of the target lesion. Yet, if the target lesion was no longer present, a biopsy was done at the site where the lesion was previously located.
Primary Outcome
The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.
Interventions
- DRUG Imiquimod 3.75% Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-04-30 |
| Phase | Phase 2 |
What the finished NCT03914417 record still lists
NCT03914417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Imiquimod 3.75% Cream is the first listed.
NCT03914417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03914417 about?
NCT03914417 is a clinical study titled "Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream". The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp. At Day 0, one Actinic Keratosis (AK) in the treatment area had been biopsied via a 3 mm punch. The tissue collected was sent to pathology for confirmato...
What is the current status of trial NCT03914417?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2013-01. Estimated completion is 2015-04-30.
What interventions are being tested in trial NCT03914417?
The interventions under investigation include: Imiquimod 3.75% Cream (DRUG).
Who is sponsoring clinical trial NCT03914417?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03914417's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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