Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

NCT ID: NCT00696488

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-10-31

Brief Summary

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

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

Conditions

Actinic Keratosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fluorouracil 0.5%

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Carac

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

References

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. doi: 10.1001/archdermatol.2008.562. No abstract available.

Reference Type: DERIVED

PMID: 19221274 (View on PubMed)

Other Identifiers

31358

Identifier Type: -

Identifier Source: secondary_id

IRB00000156

Identifier Type: -

Identifier Source: org_study_id