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Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

This study has been completed.
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences Identifier:
First received: June 9, 2008
Last updated: February 6, 2017
Last verified: February 2017
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

Condition Intervention Phase
Actinic Keratosis
Drug: Fluorouracil 0.5%
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis. [ Time Frame: 12 weeks ]
    Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: Carac

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

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00696488

United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Steve Feldman, MD, PhD Wake Forest University Health Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven R. Feldman, Professor, Dermatology, Wake Forest University Health Sciences Identifier: NCT00696488     History of Changes
Other Study ID Numbers: 00000156
Study First Received: June 9, 2008
Results First Received: February 6, 2017
Last Updated: February 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017