At a glance
ClinicalIndex Comparison Record- ✓Adults at least 18 years old
- ✓Good general health confirmed by medical history
- ✓At least 4-8 actinic keratoses on the face and/or scalp
- ✓Willing to forego other treatments on face/scalp during study, including tanning beds and excessive sun exposure
- ✕History of melanoma anywhere on the body
- ✕Non-melanoma skin cancer on the face and/or scalp
- ✕Unstable medical condition as deemed by clinical investigator
- ✕Any dermatologic disease in treatment area that may be exacerbated or impair AK evaluation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Investigator-initiated Study to Evaluate Genomic Markers of Immune Infiltration Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
In Brief
A Phase 2 clinical trial evaluating Imiquimod 3.75% Cream for Actinic Keratosis. Completed, enrolled 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).