CQI Pilot Study Evaluating the Utility of an Educational Video in the Setting of Topical 5-fluorouracil Therapy to Treat Actinic Keratoses and Its Influence on Patient Satisfaction

University of California, Davis1 site in 1 country44 target enrollmentNovember 2012

ConditionsActinic Keratoses

Overview

Phase: N/A
Intervention: Not specified
Conditions: Actinic Keratoses
Sponsor: University of California, Davis
Enrollment: 44
Locations: 1
Primary Endpoint: Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary aim of this study is to evaluate the effects of prospective patient education on patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms. Specifically, this study aims to determine if prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

June 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of California, Davis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).

Exclusion Criteria

•Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
•Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
•Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
•Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
•Patients who have known allergies to fluorouracil (5-FU).