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

Phase 4

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: Topical Steroid Ointment; Other: Vaseline; Drug: Skin Barrier Moisturier

• Registration Number: NCT03279328
• Lead Sponsor: University of Arizona

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2017-10-10
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical Steroid Ointment	Topical Steroid Ointment	One side of the face will receive a Topical Steroid ointment twice daily for seven days.
Vaseline	Vaseline	One side of the face will receive Vaseline twice daily for seven days.
Skin Barrier Moisturizer	Skin Barrier Moisturier	One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.

Primary Outcome Measures

Name	Time	Method
Skin barrier biophysical properties	2 hours	Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)

Trial Locations

Locations (1)

University of Arizona - Banner University Medicine Dermatology; 🇺🇸 Tucson, Arizona, United States