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Completed

NCT Number: NCT03279328

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, 85718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Steroid Ointment

Drug

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.

Vaseline

Other

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.

Skin Barrier Moisturier

Drug

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.

Primary outcomes

  1. Skin barrier biophysical properties

    Time frame: 2 hours

    Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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