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

Completed · Phase 4

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID

NCT03279328

Run by

University of Arizona

People needed

30

Starts

2017-10-10

Expected to finish

2018-07-31

Last updated by the study team

2019-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Arizona - Banner University Medicine Dermatology — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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