This trial is active, not recruiting.

Condition actinic keratoses
Treatments video group, verbal group
Sponsor University of California, Davis
Start date November 2012
End date March 2014
Trial size 44 participants
Trial identifier NCT02062853, 384968


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Subjects view educational video on the use of cream medication for the treatment of actinic keratoses.
video group
Subjects will view a brief video today (about 5 minutes long) that provides information on the cream medication that will be used for treatment of your actinic keratoses.
(Active Comparator)
Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses.
verbal group
The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.

Primary Outcomes

Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title 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
Principal investigator Nasim Fazel, M.D., D.D.S.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.