Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Topical Steroid Ointment
* Other: Vaseline
* Drug: Skin Barrier Moisturier


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Steroid Ointment<br>One side of the face will receive a Topical Steroid ointment twice daily for seven days. | Drug: Topical Steroid Ointment<br>* 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.<br>|
| Active Comparator: Vaseline<br>One side of the face will receive Vaseline twice daily for seven days. | Other: Vaseline<br>* 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.<br>|
| Active Comparator: Skin Barrier Moisturizer<br>One side of the face will receive Skin Barrier Moisturizer twice daily for seven days. | Drug: Skin Barrier Moisturier<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin barrier biophysical properties | Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter) | 2 hours |