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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 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03914417
The ClinicalTrials.gov registry entry for NCT03914417 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Imiquimod 3.75% Cream is the first listed.
NCT03914417 reports 0 study locations.
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.
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