Actinic Keratoses
Conditions
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.
Interventions
OTHERVideo 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.
OTHERVerbal Group
The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream | 4 weeks | The level of patient satisfaction will be assessed via questionnaire and visual analog scale. |
Countries
United States
Outcome results
None listed