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

Actinic Keratoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279328
• Other study ID #: 1708724736
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2019
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Topical 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.

Other:
• Vaseline
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.

Drug:
• Skin 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.

Locations

Country	Name	City	State
United States	University of Arizona - Banner University Medicine Dermatology	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin barrier biophysical properties	Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)	2 hours