Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

This study has been completed.

First Received: June 9, 2008 Last Updated: February 12, 2009 History of Changes

Sponsored by:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00696488

Purpose

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 IV

Drug Information available for: Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Further study details as provided by Wake Forest University:

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:

Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696488

Locations

United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Steve Feldman, MD, PhD

Wake Forest University

More Information

No publications provided by Wake Forest University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. No abstract available.

Responsible Party:	Wake Forest University Health Sciences ( Steve Feldman, MD PhD )
Study ID Numbers:	00000156, 31358
Study First Received:	June 9, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00696488 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Keratosis
Immunologic Factors
Skin Diseases

Fluorouracil
Immunosuppressive Agents
Tylosis

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Keratosis
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases

Antineoplastic Agents
Therapeutic Uses
Fluorouracil
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009