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

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Petrolatum

Criteria

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.