Official Title: “Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population”

The purpose of this research study is to see the effectiveness of 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 your actinic keratoses on your face and anterior scalp.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• 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.

Primary Measures

• Adherence to Carac® in subjects with moderate to severe actinic keratosis.
  • Time Frame: 12 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wake Forest University

Overall Clinical Trial Officials and Contacts

Steve Feldman, MD, PhD Principal Investigator Wake Forest University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00696488

Study ID Number: 00000156

ClinicalTrials.gov Identifier: NCT00696488

Health Authority: United States: Institutional Review Board