Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

This study has been completed.
Information provided by:
Wake Forest School of Medicine Identifier:
First received: June 9, 2008
Last updated: February 12, 2009
Last verified: February 2009
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.

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 School of Medicine:

Primary Outcome Measures:
  • Adherence to Carac® in subjects with moderate to severe actinic keratosis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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.
    Other Name: Carac

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
  More Information

No publications provided by Wake Forest School of Medicine

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steve Feldman, MD PhD, Wake Forest University Health Sciences Identifier: NCT00696488     History of Changes
Other Study ID Numbers: 00000156, 31358
Study First Received: June 9, 2008
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratosis, Actinic
Precancerous Conditions
Skin Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015