Actinic Keratosis
Conditions
Brief summary
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
Detailed description
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
Interventions
DRUGFluorouracil 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
Sponsors
Wake Forest University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.
Exclusion criteria
* Age less than 50. * Known allergy or sensitivity to topical Carac® in the subject. * Inability to complete all study-related visits. * Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study. * Subjects should not receive surgical or cryotherapy while participating in the study. * Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis. | 12 weeks | Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluorouracil 0.5% 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
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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Fluorouracil 0.5% |
|---|---|
| Age, Continuous | 67 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fluorouracil 0.5% | Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis. | 86 percentage of prescribed doses |