Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Actinic Keratosis

Treatments: Drug: Fluorouracil 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT00696488

IRB00000156

31358

Details and patient eligibility

About

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

Full 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

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Fluorouracil 0.5%

Experimental group

Description:

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

Treatment:

Drug: Fluorouracil 0.5%