Back to resultsMeasuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluorouracil 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Health Sciences Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fluorouracil 0.5%
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00696488
Brief Title
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Official Title
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluorouracil 0.5%
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fluorouracil 0.5%
Other Intervention Name(s)
Carac
Intervention Description
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
Primary Outcome Measure Information:
Title
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
Description
Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19221274
Citation
Yentzer B, Hick J, Williams L, Inabinet R, Wilson R, Camacho FT, Russell GB, Feldman SR. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. 2009 Feb;145(2):203-5. doi: 10.1001/archdermatol.2008.562. No abstract available.
Results Reference
derived
Learn more about this trial
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
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