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

Sponsor

University of Arizona (Other)

Overall Status

Completed

CT.gov ID

NCT03279328

Collaborator

(none)

Enrollment

Location

Arms

9.7

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Drug: Topical Steroid Ointment Other: Vaseline Drug: Skin Barrier Moisturier	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2017

Actual Primary Completion Date :

Jul 31, 2018

Actual Study Completion Date :

Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topical Steroid Ointment One side of the face will receive a Topical Steroid ointment twice daily for seven days.	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.
Active Comparator: Vaseline One side of the face will receive Vaseline twice daily 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.
Active Comparator: Skin Barrier Moisturizer One side of the face will receive Skin Barrier Moisturizer twice daily 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.

Arm

Intervention/Treatment

Active Comparator: Topical Steroid Ointment

One side of the face will receive a Topical Steroid ointment twice daily for seven days.

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.

Active Comparator: Vaseline

One side of the face will receive Vaseline twice daily 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.

Active Comparator: Skin Barrier Moisturizer

One side of the face will receive Skin Barrier Moisturizer twice daily 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona - Banner University Medicine Dermatology	Tucson	Arizona	United States	85718

Sponsors and Collaborators

University of Arizona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT03279328

Other Study ID Numbers:

1708724736

First Posted:

Sep 12, 2017

Last Update Posted:

Jun 25, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Keratosis, Actinic

Keratosis

Petrolatum

Study Results

No Results Posted as of Jun 25, 2019