A Phase 4 interventional study of Fluorouracil 0.5% in Actinic Keratosis, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Wake Forest University · Phase 4, Interventional, and Treatment
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
Drug: Fluorouracil 0.5%
Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions
Also known as: Carac
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
Time frame: 12 weeks
| Milestone | Fluorouracil 0.5% |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
| percentage of prescribed doses | Fluorouracil 0.5% |
|---|---|
| Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis. | 86 (54 to 100) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluorouracil 0.5% | — | 0/20 (0%) | 2/20 (10%) |
| Event | Fluorouracil 0.5% |
|---|---|
| Burning of skinSkin and subcutaneous tissue disorders | 2/20 |
| Age, Continuous(years) | Fluorouracil 0.5% |
|---|---|
| Mean | 67 (51 to 91) |
| Sex: Female, Male(Participants) | Fluorouracil 0.5% |
|---|---|
| Female | 1 |
| Male | 19 |
| Region of Enrollment(participants) | Fluorouracil 0.5% |
|---|---|
| United States | 20 |
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University