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Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00696488
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : March 27, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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Brief Summary:
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Fluorouracil 0.5% Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Study Start Date : April 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696488


Locations
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United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Steve Feldman, MD, PhD Wake Forest University Health Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00696488    
Other Study ID Numbers: IRB00000156
31358
First Posted: June 12, 2008    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs