Actinic Keratoses
Conditions
Brief summary
This proposed project will be an open-label, split face, randomized controlled pilot study. Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The purpose of this study is to understand the change in skin appearance throughout 5-FU treatment course and to examine whether a topical corticosteroid and moisturizer can decrease severity and duration of skin inflammation after 5-FU treatment course.
Detailed description
The purpose of this study to understand the change in skin appearance during and after the course of 5-FU cream in patients with AK, and compare how the appearance of skin inflammation changes with the use of topical corticosteroids and moisturizers.
Interventions
DRUGTopical Steroid Ointment
Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
OTHERVaseline
Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
DRUGSkin Barrier Moisturier
Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female, at least 18 years of age * Subject must have a diagnosis of actinic keratosis (at least 5 lesions on each side of the face) * Able to comprehend and read the English language
Exclusion criteria
* Subjects who do not fit the inclusion criteria * Concurrently have other inflammatory skin conditions. * Prior known allergy to any components to of 5FU cream, topical steroid ointment or vaseline. • Subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures (i.e.: compliant with using 5-FU cream, topical corticosteroid or moisturizers * Those that are prisoners or cognitively impaired.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin barrier biophysical properties | 2 hours | Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter) |
Countries
United States
Outcome results
None listed