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Completed

NCT Number: NCT00696488

Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

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

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil 0.5%

Drug

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 names: Carac

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jun 12, 2008
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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