Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Phase 4

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Fluorouracil 0.5%

• Registration Number: NCT00696488
• Lead Sponsor: Wake Forest University

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

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-08
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Study Completion: 2008-10
• Results First Submitted: 2017-02-06
• Results First Submitted QC: 2017-02-06
• Results First Posted: 2017-03-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorouracil 0.5%	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wake Forest University Health Sciences Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States