Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
Status:
Completed
Trial end date:
2015-04-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.