Trial Outcomes & Findings for Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population (NCT NCT00696488)

Results Overview

Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-09-10

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Baseline characteristics by cohort
Measure	Fluorouracil 0.5% n=20 Participants 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
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

Timeframe: 12 weeks

Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used

Outcome measures
Measure	Fluorouracil 0.5% n=20 Participants 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
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.	86 percentage of prescribed doses Interval 54.0 to 100.0

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Fluorouracil 0.5% n=20 participants at risk 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
Skin and subcutaneous tissue disorders Burning of skin	10.0% 2/20 • Number of events 2

Wake Forest University Health Sciences

Phone: 336-716-3775